Sr. QA Inspector - 3rd Shift @ Simtra BioPharma Solutions
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Job Details
Overview
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, Simtra focuses on cGMP manufacturing and high quality standards.
About the Role - Sr. QA Inspector - 3rd Shift
The Sr. QA Inspector is a key member of the Finishing Quality Assurance Team. Reporting to the Quality Finishing Line Operations Supervisor/Manager, you will ensure that all GMP products produced on the finishing lines meet an acceptable quality level (AQL) and support first line Quality Assurance on production lines. The role involves making risk-based decisions for minor issues online and contributing to a culture of teamwork and continuous improvement.
Schedule and Responsibilities
- Work on the 3rd shift: Sunday-Friday 10:45pm to 6:24am (some weekends as needed).
- Monitor product quality through AQL inspections.
- Provide first line QA support and cross-train in QA Label Control and QA Warehouse functions.
- Assist in the inspection of labeling materials and reserve sample releases.
Desired Qualifications
- High School diploma or GED.
- Minimum 2 years in pharmaceutical or biotech industry.
- Proficiency in Microsoft Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Pilgrim).
Physical & Safety Requirements
- Must lift 30 lbs and perform various physical tasks (bending, twisting, kneeling, stooping).
- Vision requirements: 20/20 corrected vision with colorblindness test passing.
- Ability to sit and stand for extended periods; wear required PPE.
Benefits
Simtra offers competitive benefits including medical, dental, life insurance, 401(k) with match, paid time off, and many additional perks such as adoption reimbursement, education assistance, and onsite amenities like workout facilities and a cafeteria.
Key skills/competency
Sr. QA Inspector - 3rd Shift: GMP, AQL, Quality Assurance, Inspection, cGMP, risk, cross-training, biopharma, regulatory, teamwork.
How to Get Hired at Simtra BioPharma Solutions
🎯 Tips for Getting Hired
- Research Simtra BioPharma Solutions: Review company values and recent news.
- Customize your resume: Highlight cGMP and inspection experience.
- Prepare for technical questions: Understand AQL and regulatory standards.
- Practice behavioral questions: Emphasize teamwork and risk decisions.