Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To undertake microbiological tasks and analysis for the release and monitoring of facilities, raw materials, intermediate and final product samples according to defined procedures and protocols, in accordance with regulatory requirements.

Responsibilities:

  • Execute microbiological procedures for testing of raw materials, intermediate products and final product samples, according to defined SOPs and protocols
  • Perform environmental monitoring of cleanroom areas as required, to support manufacturing processes and Facility Contamination Control (FCC)
  • Conduct all activities in a careful and safe manner and in full compliance with HSE requirements
  • Ensure that all required training is complete in procedures performed and operate in compliance with regulatory requirements
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to Line Manager
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Be accountable for QC areas being clean, tidy and well organised and in a state of continuous inspection readiness
  • Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Undertake any other duties in accordance with company requirements
  • Undertake shift work and/or support activities that require to be performed out of normal business hours, when requested, to support business priorities

Experience:

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory body requirements
  • Experience of microbiological methods in a production-focused environment including but not limited to; Total Viable Count, Bacterial Endotoxin, Environmental monitoring, Microbial Identification and Growth Promotion
  • Minimum of 1 Year relevant Industry Experience
  • Biologics / vaccine background ideal
  • Experience of Quality Management Systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience managing external relationships for effective delivery, e.g. vendors, test houses

Skills:

  • Ability to organise, deliver planned schedules and work across QC, Process Development and QA
  • Experience of writing QMS documentation, e.g. SOPs, Deviations, Change Controls, CAPA desired
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels within and outside QC
  • Ability to contribute effectively to successful teamwork, and work independently and manage own workload when required

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. 

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.

Job Summary

To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.

Responsibilities

  • Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
  • To manage Microbiology activities in support of manufacturing schedules and support FCC activities
  • Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
  • Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
  • Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
  • Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
  • Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
  • Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
  • Manage and co-ordinate on time delivery of QMS documentation by the team
  • Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
  • Ensure high standards of housekeeping are maintained within areas of responsibility
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
  • Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
  • Contribute, encourage and support staff development activities
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Support shift and out of normal hours work, including weekends, as required to support business requirements
  • Deputise for the Head of QC during times of absence or a need for technical expertise

Experience

  • Educated to degree level or equivalent experience
  • Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
  • Knowledge of GMP guidelines and regulatory bodies
  • Previous supervisory experience in a lab environment preferred

Required Skills

  • Ability to lead and co-ordinate work within a busy QC laboratory
  • Ability to motivate and engage an effective workforce
  • Ability to develop and manage change projects effectively and efficiently
  • Effective communication and presentation skills (for internal and external interactions)

 

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung, Revision und Verifizierung analytischer Daten
  • Erstellung, Revision und Überprüfung der GMP-relevanten Dokumenten (zB Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Zumindest 4 Jahre Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according to best cGMP work practices, Quality Standards and metrics, as well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva.  Carry out laboratory tasks as identified by QC department.

Responsibilities

  • Inspection and labelling of Incoming Goods
  • Maintain raw material specifications to ensure continued compliance with current pharmacopoeias (e.g. Ph.Eur., USP)
  • Support / co-ordinate the testing and release of raw materials, ensuring uninterrupted supply of materials to Manufacturing and QC for the manufacturing process
  • Apply best GMP work-practices and techniques to sampling
  • Support co-ordination of the storage of QC reference samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Support co-ordination of sample logistics for all testing, applying best cGMP work-practices and techniques to sampling and management for the release of raw materials ensuring continuous availability of materials into manufacturing and QC to meet production forecast
  • Progress QMS to ensure on time delivery and compliance within the QC department
  • Prepare and submit Purchase Orders for raw material external testing
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas
  • Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
  • Support QC activities in line with manufacturing schedule, as per rota (including provision of overtime cover as required)
  • Shift work and out of hours work as required
  • Identify continuous improvement opportunities and liaise with QC line management (or other functions) to agree benefits and deployment plans
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Actively contribute to the development of the QC Logistics team, for example, through team meetings
  • Act as departmental point of contact on relevant site projects
  • Support other QC activities in line with the manufacturing schedule

Experience

  • Degree / HND / HNC in chemical/biological sciences or relevant experience
  • Knowledge of usage of Pharmacopoeias is beneficial but not essential
  • Knowledge of GMP guidelines and regulatory bodies
  • Experience in method validation / verification is beneficial but not essential
  • Experience of Quality Management Systems
  • Experience in working with Microsoft Excel, and ERP systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience working effectively in a team, influencing as appropriate

Skills

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player
  • Ability to think analytically

FIXED-TERM CONTRACT (1,5 years)

YOUR RESPONSIBILITIES

  • Site functional lead for Quality Control (QC) of marketed products. Lead and develop local site QC team Local line management responsibilities for QC Analytics (QCA) and Sample Management Departments (20 employees). Site Quality Control responsibilities including QC testing (release, stability, and raw material) and management of samples.
  • Coordinate in vivo experiments with Laboratory Animal Facility and ensure compliant set-up in vivo QC testing (release and stability).
  • Assure compliance with cGMP of all QC facilities, equipment, systems, and processes
  • Keep up to date with current GMP guidelines, relevant pharmacopoeia and scientific knowledge in respect to QC testing requirement and methods.
  • Technical oversight of tech transfer and all external QC testing activities.
  • Assure that external and internal regulations for Environment, Health and Safety are fulfilled for all QC staff, facilities, systems and processes.
  • Responsible for review/approval of QC test data, and QC-batch/sample result release, including trending, sample related deviations, Out of specification (OOS) and Out of control (OOC) investigation and timely escalation.
  • Responsible for providing technical expertise support from QC to investigations and technical matters.
  • Responsible for QCA test plans and internal QC resource planning to ensure timely delivery of QC results.
  • Responsible for defining and maintaining the direct cost budget for the QC cost centers
  • Review and approval of specifications, validation and qualification documents, as well as standard operation procedures of analytical methods and sample management
  • Responsible for QC employees to have the necessary qualification, practical experience and competency.
  • Responsible for premise and equipment to be maintained to suit its intended purpose

YOUR QUALIFICATIONS

  • Bachelor or Master Degree in Natural Sciences, with extensive work experience in the Life Science or Pharmaceutical Industry,
  • Minimum of 5 years’ work experience within GxP regulated Life Science or Pharmaceutical Industry
  • Experience of relevant GxP (GMP, GCP, GCLP) requirements for QC for the EU, US and Canadian markets in a commercial environment
  • Used to work in an international environment with various cultures is desirable
  • Strong management and leadership skills with ability to motivate and engage
  • Proactive, solution-oriented and able to react in a fast changing environment
  • Ability to manage and prioritize workload both for the organization as well as on a personal level
  • Business fluent in English and German

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 65.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Job Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according with best cGMP work practices, Quality Standards and metrics. As well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities:

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Apply best cGMP work practices and techniques to test and release raw materials and product within specification
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with best cGMP working practices at all times
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of QC
  • Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that at any time equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s in the post diligent manner
  • Identify areas for continuous improvement and escalate those to the Head of QC
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintain adequate stocks of materials and equipment and laboratory consumables
  • Assist in monitoring and maintaining calibration status of all equipment within the Quality Control department
  • Calibration of pipettes and informing relevant personnel in a timely manner of any failure of calibration
  • Arrange subcontract of QC testing and dispatch to approved suppliers and provide support to the Logistics department
  • Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
  • Storage of in process, and final products samples including, for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the line manager or Head of QC
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Shift work and out of hours work as required

Experience:

  • A minimum of 2 years’ experience working within a QC laboratory working to GMP within a recognised quality system
  • Writing and working to SOP documentation
  • Analytical methods experience, in a production-focused environment, in assays (not limited to) Haemagglutination assays, micro-plate assays such as ELISA and dye binding colorimetric assays (Bradford Method, Coomassie Plus), Electrophoresis, TVC and UV Spectrophotometry
  • Assay development, validation and transfer experience desirable
  • Experience of working within Quality Management Systems which include deviations, change controls and CAPA’s
  • Cell culture and Microbiological experience would be preferable
  • Plaque testing and ELISA experience highly desirable
  • Proven track record of being able to maintain the highest standards of hygiene and
    cleanliness in a laboratory environment
  • All round experience of working within a laboratory environment

Skills:

  • Capability to organise and schedule work within a busy laboratory
  • Knowledge of GMP guidelines and regulatory bodies
  • Well organised, self-motivated individual
  • Ability to follow instructions and manage workload to meet expected work schedules

Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 750 employees.

Summary

Co-ordination of QC sample management, including shipments and supporting QC activities, in accordance with defined procedures, protocols and regulatory guidelines.

Responsibilities

  • Shipment of QC samples and materials, including viral samples, to approved external test houses according to defined procedures, schedules and in compliance with GMP and Dangerous Goods regulations including the preparation of shipment documentation and samples
  • Embrace a flexible way of working and respond efficiently to changes to the shipment schedule
  • Support co-ordination of the storage of QC samples including maintenance of inventory logs, execution of routine stock checks and discard of applicable materials
  • Support QC activities in line with manufacturing schedule as per QC rota. QC activities include sample receipt from Manufacturing and sample storage, calibration of balances, checking of labels, documentation review and occasional coverage of Total Viable Count testing. This includes provision of overtime cover as required, i.e. coverage of late and weekend QC rota, where required
  • Progress QMS in a timely manner, to ensure on-time delivery
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to line manager
  • Maintain all QC systems, databases, logs and support the generation of QC trend data
  • Adhere to 5S working practices. Identify and implement areas for continuous improvement and escalate to line manager
  • Be accountable for the QC areas being clean, tidy and well-organised and in a state of continuous inspection readiness
  • Perform routine housekeeping activities in QC including cleaning of equipment and laboratory areas and maintenance of equipment including replenishment of liquid nitrogen tanks
  • Ensure that all required training is complete in procedures performed and operate in compliance with best cGMP working practices at all times
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintenance of GMP documentation, e.g. review and archiving
  • Shift work and out of hours work as required
  • Undertake any other duties in accordance with company requirements

Experience

  • Degree in biological sciences or relevant experience
  • Knowledge of GMP guidelines and regulatory bodies or biologics/vaccine background would be an advantage
  • Experience managing external relationships for effective delivery i.e. suppliers would be an advantage
  • Experience of Quality Management Systems would be an advantage
  • Experience of raw material testing, sample management and shipping would be an advantage
  • Experience of working to deadlines and managing conflicting priorities

Skills

  • Ability to organise and schedule work within a busy QC department
  • Experience of working to SOP documentation
  • Excellent time management and prioritisation skills
  • Ability to communicate at all levels
  • Flexible and able to efficiently adapt to organisational changes
  • Ability to utilise resources to solve problems
  • Strong attention to detail