Senior QC Technician (Analytical)

Valneva SE; Michigan; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Stock Options

Employee Assistance Programme

Gym membership

EV Salary Sacrifice

Job summary

Valneva SE is seeking a Senior QC Technician (Analytical) to supervise and perform analytical tests for the release of raw materials and intermediates according to defined procedures. You will provide technical expertise in analytical assays and drive projects to completion while supporting the Analytical Manager.

The role requires coordinating QC testing, ensuring cGMP practices, training staff, and maintaining inspection-ready laboratories.

Qualifications

• GMP in QC laboratory environment.
• Experience writing and following SOP documentation.
• Extensive QMS experience: OOS, Change Control, Deviations.
• Experience in biological assays.

Responsibilities

• Coordinate, schedule and execute raw material, stability and in-process testing.
• Provide technical expertise in analytical procedures (Haemagglutination/ELISA/etc).
• Apply cGMP practices to test and release materials.
• Ensure staff are trained and competent in procedures.
• Develop, report and use QC metrics for continuous improvement.
• Prepare and verify analytical data per documentation standards.
• Escalate deviations to the QC Manager promptly.
• Maintain clean, organized labs and readiness for inspections.
• Maintain lab equipment and daily operations support.
• Write and review QMS documentation (SOPs, OOS/OOT, Change Control, Deviations, CAPAs).
• Represent QC in cross-functional planning and batch release meetings.
• Provide Analytical SME support as required.
• Identify improvement areas and promote team development.
• Support out of hours testing to meet production schedule.
• Evenings/weekend work as required with shift allowance.

Skills

GMP in QC lab

SOP documentation

QC testing

Analytical assays

Team leadership

Tools

Minitab

Job description

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.

Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

Our QC team are currently hiring for a Senior QC Technician (Analytical) who will supervise andperformAnalyticaltests for the release of raw materialsandintermediate products according to defined procedures and protocols.Provide technicalexpertisein analytical assays and drive analytical projects to completion to agreed timelines.Oversee the daily running of the laboratories and support the Analytical Manager.

Due to the nature and training requirements of this role, applicants must have the legal right to work in the UK, We are unable to provide Visa Sponsorship for this role.

• To co-ordinate, schedule and execute raw material, stability and in process real-time analytical laboratory testing.
• Provide technical expertise in analytical procedures that may include Haemagglutination Assay, Protein Assays, ELISA, Cell Culture, Plaque Testing, pH testing, Osmolality testing, TVC testing.
• Apply cGMP work-practices and techniques to test and release raw materials and intermediate products.
• Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting and are following cGMP working practices at all times.
• Be responsible for the development, collating and reporting of key quality and business metrics, and use such metrics to drive a culture of continuous process improvement within the area of responsibility.
• Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Technicians.
• Immediately escape and report any deviations to materials, facilities, processes or procedures to the Manager.
• Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness.
• Manage the daily maintenance of laboratories and equipment required to adequately support routine laboratory activities.
• Write QMS documentation including SOP’s, OOS/OOT, Change Control, Deviations, CAPA’s.
• Represent QC in cross-functional planning, batch release and project meetings.
• Provide support as an Analytical Subject Matter Expert (SME) as required.
• Identify areas for continuous improvement and elevate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• To undertake any other duties as requested by the line manager in accordance with company requirements.
• Contribute, encourage and support staff development activities.
• Support out of hours real-time testing, adapting to the production schedule.
• Evenings/weekend work as required to support production schedule (Additional shift allowance).

Experience

• Working within a QC laboratory environment, working to GMP within a recognised quality system
• Ability toprioritise,organise and schedule work within a busy laboratory
• Experience of writing and working to SOP documentation
• ExtensiveQMS experience, OOS, Change Control, Deviations.
• Experience in biological assays.
• Experience in reference standard management.
• Experience driving a team to achieve individual, team and organisationalobjectives.
• Experienced in relationship handling with external bodies, such as suppliers,regulatory and audit authorities.

Preferred

• Virologyexpertise.
• Use of Minitab Statistical Software.
• Experience conducting lab tours and technical discussions with regulatory inspectors.
• Validation and qualification of assays knowledge would beadvantageous.
• Stock Options
• Employee Assistance Programme
• Gym membership OR fitness allowance
• EV Salary Sacrifice
• Many others included