|Job Purpose |
|Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that Vaccines samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.|
|Major Accountabilities |
- Performs testing and associated tasks without errors per applicable SOPs and protocols.
- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
- Participates in lean lab operation, 6S laboratory layout, KATA, preventive action & continuous improvement programs to reduce operating costs
- Performs shift-work as necessary to support manufacturing
- Participates and performs in cross-training to support staff availability within QC department
- Develops and maintains SOPs
- Develops expertise in assigned assays/techniques
- Authors deviation and invalid assay assessments
- May be required to perform shift work as required to support operations