Commercial Quality Assurance Inspector

2 weeks ago

Mississauga, Canada PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title:
Commercial Quality Assurance Inspector Locations:
Mississauga, ON Business Type:
Commercial Department/Function:
Quality Reports to:
Compliance and QA Inspector Supervisor FLSA Status:
Hourly Prepared By:
Sharlett Burgess
Approved By:
Sharlett Burgess
Summary of Objective:
Responsible for achieving quality standards during the production process. Monitors production for compliance to customer specifications, GMP, pharmaceutical standards and internal SOP’s. Performs line audits, final inspections as well as Line Clearance verifications. Responsible for pulling and labeling client requested samples (i.e., stability). The QA Inspector role reports to the Compliance and QA Inspector Supervisor. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. 1. Consistently applies company SOPs relative to production, quality, and pharmaceutical standards. 2. Partners with Operations Personnel (i.e., Operations Manager, Production Supervisor, Production Line Leaders, Packagers, Maintenance Supervisor, Mechanics) and Quality 3. Assurance Personnel (i.e., QA Associates) in assessing product quality. 4. Involved in start-up challenges and verification of correct lot/expiry date prior to start of the run. 5. Performs line audits during shift to ensure PBR and SOPs are being followed. 6. Conducts sampling routines 7. Evaluates finished goods and recommends the approval or rejection of work accordingly. 8. Communicates issues and production problems to Operations Personnel and Quality, Assurance Personnel. Makes suggestions and helps where appropriate, to ensure production is expedited. 9. Acts as a line of communication between the Packaging Rooms and the Compliance and QA Inspector Supervisor. 10. Assists in the investigation and resolution of quality problems. 11. Undertakes the writing, revision, and documentation of SOP’s. 12. Responsible for educating Operations Personnel (i.e., Production Supervisor, Line Leaders, Packagers and Mechanics) in SOP’S. 13. Assists the Compliance and QA Inspector Supervisor with the development of policies, procedures, and work practices. 14. Assists the Quality Director and Compliance and QA Inspector Supervisor with audits as requested. 15. Performs Line Clearances. 16. Responsible for approving completed logbook pages as required. 17. Checks and records room pressures on a daily basis 18. Responsible for monitoring and adhering to safety practices, raising concerns or issues to the appropriate level. 19. Back up support to the various functions of the QA Team as required 20. This position may require overtime and/or weekend work. 21. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. 22. Attendance to work is an essential function of this position. 23. Performs other duties as assigned by Manager/Supervisor.
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions - Stationary Position: From 1/2 to 3/4 of the day. - Move, Traverse: Up to 1/4 of the day. - Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up. - Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up. - Ascend/Descend or Work Atop: Up to 1/4 of the day. - Position self (to) or Move (about or to): From 1/2 to 3/4 of the day. - Communicate or exchange information: 3/4 of the day and up. - Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 50 pounds between 1/4 and 1/2 of the day. This position may have the following special vision requirements. Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception Ability to focus No Special Vision Requirements Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.Extreme cold (non-weather) for up to 1/4 of the day.Toxic or caustic

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