Quality Assurance/Control Inspector

About the role

The QA Floor Inspector provides review of in-process test data and batch documentation to limit the need for later review or rework. As the Quality expert on the production floor, you will guide and advise operations associates on cGMP’s and Good Documentation Practices to ensure timely release of product or reaction to issues.

Responsibilities

• Investigate discrepancies or adjust errors.
• Conduct approval of pre-start-up activities including line/room clearance and initial equipment checks when required.
• Perform in-process testing verifications of operations data to confirm consistency in testing methodology and test data.
• Consistently review in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOPs, and cGMPs.
• Discuss errors directly with line personnel so corrections can be made if required.
• Collect data on FPQ and perform release of batch records.
• Perform daily compliance audits for responsible areas within production.
• Conduct duties in compliance with safety rules, applicable SOPs, and cGMP Guidelines.
• Work in an environment that may be exposed to powders, chemicals, and allergens.

Requirements

• High organizational skills.
• High attention to detail.
• Excellent written and oral interpersonal communication skills.
• Intermediate to advanced computer knowledge of MS Office programs (Outlook, Excel, and Word).
• Physical ability to repetitively lift (up to 50 lbs.), stand, bend, climb, etc., within an operations environment.
• High school diploma or general education degree (GED).
• Compliance with company policies and procedures and exceptional work attendance.

Qualifications

• Prior quality experience in a pharmaceutical or related manufacturing environment.
• Experience with production equipment functionality and Quality Assurance Systems is preferred.
• Experience working with computer software such as AS400, Captiva, and PDM software is preferred.
• Understanding of mathematical functions, such as mean, median, average, and standard deviation is preferred.