QA Inspector

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QUALITY ASSURANCE INSPECTOR

JOB SUMMARY

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.

SKILLS, KNOWLEDGE / EXPERIENCE REQUIRED TO PERFORM THE JOB
- University/college education in the fields of math, or science, or relevant practical experience.
- Knowledge and experience with manufacturing processes and products.
- Exceptional attention to detail and proofing ability.
- Sound judgement when approving or rejecting work in keeping with specifications and internal quality control standards.
- Effective interpersonal skills and the ability to influence and negotiate in the presentation of feedback to colleagues and superiors.
- Computer knowledge to use software programs such as Access, Word, Excel, Internet, and custom company software, (ERP).
- Excellent organizational, and time management skills to ensure deadlines are met.
- Knowledge of GMP and pharmaceutical standards is an asset.

MENTAL EFFORT REQUIREDTO PERFORM THE JOB

Concentration and intense visual discernment during the scrutinizing and proofing of work. Attention to detail when utilizing the PC and data entering information. Mental attentiveness and professionalism with providing commentary or co-ordinating people and tasks. Requires an ability to multitask.

PHYSICAL EFFORT TO PERFORM THE JOB

Requires a significant amount of walking and standing on a concrete floor. Also requires a moderate amount of lifting to 50 lbs, and moderate bending and twisting. Works at a computer terminal for short periods of time.

ESSENTIAL DUTIES AND RESPONSIBILITIES
- Consistently applies company SOPs relative to production, quality, and pharmaceutical standards.
- Partners with Operations Personnel (i.e., Operations Manager, Production Supervisor, Production Line Leaders, Packagers, Maintenance Supervisor, Mechanics) and Quality Assurance Personnel (i.e., QA Associates) in assessing g product quality.
- Involved in start-up challenges and verification of correct lot/expiry date prior to start of the run.

Job Description - QA Inspector R03 April 2021 1

QUALITY ASSURANCE INSPECTOR
- Performs line audits during shift to ensure PBR and SOPs are being followed.
- Conducts sampling routines
- Evaluates finished goods and recommends the approval or rejection of work accordingly.
- Communicates issues and production problems to Operations Personnel and Quality Assurance Personnel. Makes suggestions and helps where appropriate, to ensure production is expedited.
- Acts as a line of communication between the Packaging Rooms and the Compliance and QA Inspector Supervisor.
- Assists in the investigation and resolution of quality problems.
- Undertakes the writing, revision, and documentation of SOP’s.
- Responsible for educating Operations Personnel (i.e., Production Supervisor, Line Leaders, Packagers and Mechanics) in SOP’S.
- Assists the Compliance and QA Inspector Supervisor with the development of policies, procedures, and work practices.
- Assists the Quality Director and Compliance and QA Inspector Supervisor with audits as requested.
- Performs Line Clearances.
- Responsible for approving completed logbook pages as required.
- Checks and records room pressures on a daily basis
- Responsible for monitoring and adhering to safety practices, raising concerns or issues to the appropriate level.
- Responsible for other duties as required.

SUPERVISION

Reports to the Compliance and QA Inspector Supervisor. Receives technical guidance from the QA Associate’s. Established work schedule based on production needs.

WORKING CONDITIONS WHILE PERFORMING THE JOB

Works in climate controlled GMP facility (i.e., warehouse and packaging rooms). Exposure to cold temperatures (cold room). Limited exposure to non-potent pharmaceuticals. Works with frequent interruptions both in person and by telephone.

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Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal_
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expres