Ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products.
Requirements
- cGMP experience in a regulated environment
- Aseptic Gown Qualification
- AQL Certification, including successful eye exam to support visual inspection
- Fluent in all aspects of SMS pertaining to L1 as specific to the QA Analyst role
- Sampling technique
- Detail oriented
- Accessing aseptic processing areas, sterile gowning
Responsibilities
- Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels.
- Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation.
- Interact successfully within the highly energized production and regulatory environments, to ensure compliance, mitigate risk, and ensure products are safe for patients.
- Communicate and Escalate non-conformances.
- Lead small scale projects.
- Perform CCA sampling.
- Support off-day / holiday coverage (with in lieu of days) as required to support production.
Other
- Bachelor’s Degree in Science, with ≤ 3 years quality experience preferred
- Ability to read/write/understand procedures
- Decision making with guidance commensurate on experience level
- Ability to coach production on techniques/processes to procedure requirements
- Demonstrate leadership qualities within the organization
- Ability to perform daily functions and with little supervision
