Quality Control Analyst

1.   Monitor equipment and instrumentation used on a regular basis to ensure proper operation and calibration. Identify and alert supervisor of issues on instruments and/or test executions; Trouble shoot equipment issues and make initial recommendations for possible solutions and/or corrective actions.

2.   Operate analytical instrumentation (e.g. HPGe, Lighthouse Particle Counter, SAS, & balances).

3.   Log and maintain all reference standards used to support QC testing while ensuring GDP.

4.   Participate in the construction and/or revision of SOPs, WI’s, log books, and checklists.

5.   Develop and qualify Quality Control (QC) test methods.

6.   Support and/or perform qualification and validation activities for testing equipment.

7.   Coordinate testing with contract laboratories, additional company sites, and vendors.

8.   Perform incoming inspection of raw materials and components.

9.   Perform Environmental Monitoring in accordance with all applicable standards for ISO Classified cleanrooms.

10. Assist in the execution of all microbiology protocols and review/verify analytical and/or microbiological data and reports, ensuring accuracy and consistency.

11. Train other analysts to perform QC testing and procedures.

12. Ensure that suitable written records are kept in accordance with cGMP guidelines and company procedures.

13. Maintain accurate QC inventories and order supplies as needed for QC testing.

14. Maintain QC areas which includes routine housekeeping activities.

15. Receive, distribute, track, and coordinate cGMP samples for testing.

16. Participate in internal assessments and regulatory audits as required.

17. Document deviations and laboratory out-of-specification (OOS) investigations.

18. Effectively communicate safety and quality issues raised by staff in a timely fashion.

19. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.