The role of the QC Sample Management Team Supervisor (18 month Fixed Term Contract) is to effectively coordinate and support site with all sample management activities, from receipt and distribution to the relevant labs internally to the shipping of sample to 3rd party laboratories (other Seqirus sites, external test laboratories and regulatory labs). Also responsible for the control of retains in compliance with ICH, WHO, the company quality guidelines and SOP’s and other regulatory requirements.
Responsibilities
- To provide direction to the team and ensure that mandatory training is in place. To encourage optimal performance of staff through training, feedback, coaching and development planning in conjunction with the manager. To track attendance and timekeeping and lead disciplinary / counselling sessions. Actively promote positive change.
- To ensure appropriate standards of cGMP, housekeeping, Health and Safety and Environment are applied in the team, in accordance with current regulations and procedures. To be permanently inspection ready.
- To ensure the maintenance and qualification of the specified equipment within is kept up to date and at the required GMP standards. To ensure the use of only approved and validated test processes.
- To own and investigate deviations arising from sample management activities.
- To coordinate the site sample management activities. Oversee the aseptic sampling requirement of manufacturing, stability and raw material samples. Coordinate the receipt and distribution of samples from secondary manufacture to the QC Labs. Coordinate with QA and supply chain department the requirements of OMCL samples to support batch release.
- To track the receipt of third-party samples against the shipping schedule and routine/stability sample requests escalating any delays in receipt of samples to the stability manager. Coordinate the sampling of third-party routine samples and distribution to the laboratories in a timely manner to prevent delays to batch release. Coordinating the receipt of stability samples, reserve samples and retain samples from third party suppliers and store/distribute following site procedures.
- To participate in improvement project teams (e.g., Lean labs) where required driving quality decisions and provide advice and technical support where required. Coordinate completion of and resulting activities.
- Manage the storage, annual inspection and disposal of the final product retain samples on behalf of the site Qualified Person(s).
Education
- Bachelor’s degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.).
Capabilities
- Proven quality control experience in the pharmaceutical/biotech/or other regulated industry.
- Leadership/ team management skills.
- Direct interaction with regulatory agencies.
- Knowledge of current Good Manufacturing Practices (cGMP) principles.
- Knowledge of FDA and EMA requirements.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
#LI-MS1
This position is also available as a secondment opportunity to internal employees
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
We want Seqirus to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Seqirus!
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus