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Center Quality Manager

Company: N/A

Location: Lewiston, ME, ME

Pay: $47,500.00 /Year

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Job Description


About Us


BPL Plasma is dedicated to the collection of plasma for life-saving therapies. For over 25 years, our product has been used to treat immune deficiencies and bleeding disorders, in addition to shock, trauma, and burn patients. BPL Plasma currently operates 34 FDA licensed blood plasma collection centers throughout the United States. We are growing rapidly in order to provide even more life-saving treatments to those in need. 




Purpose:

The purpose of this position is to manage donor center QA staff and ensure quality standards within the center. The Center Quality Manager has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

Job Requirements

 Key Accountabilities:

1. Manages center Quality Assurance staff to include training, performance evaluation, career development, compensation administration and progressive discipline as needed per company policies and procedures.

2. Coordinates the scheduling of the center Quality Assurance staff.

3. Guarantees data integrity by reviewing all aspects of the manufacturing process to ensure the completeness, and accuracy of records and documents within the quality systems.

4. Analyzes deviation tracking and trending data and implements appropriate CAPA to improve compliance and quality.

5. Plans and presents quality topics during regularly scheduled staff meetings and hosts a weekly QA staff meeting with Operations Management and Quality Assurance staff.

6. Manages on time resolution of error investigations and CAPA.

7. Drives center level CAPA initiatives generated from tracking and trending analysis.

8. Ensures final QA review and release for all product shipments and associated documents to ensure shipments meet regulatory customer specifications as needed.

9. Co-hosts customer, regulatory, and corporate audits of the center. In conjunction with regional and center management, completes all audit responses, including corrective/preventive action, and ensures that responses are submitted on time.

10. Partner with Training Coordinator to ensure that new hire and SOP training occurs and is effective.

11. Other job related responsibilities as required.



Qualifications:

1. Bachelor’s degree in life science or related field preferred.