QA Supervisor - Erie, PA

Proclinical, in support of our client, are seeking an individual to fill the role of Quality Assurance Supervisor, to join our growing biopharmaceutical company and assist in opening our newest Donor Center. Reporting into the Regional Director of Operations, this position is responsible for the overall quality program of the Donor Center. You will provide advice and consultation to other management team members regarding daily quality assurance issues including donor suitability and/or product quality.

Responsiblities

• Determine if quality activities and manufacturing records follow SOPs and regulatory requirements.
• Perform final QA review and release for all product shipments.
• Perform regular quality compliance audits of the center activities.
• Provide direction and oversight to the Quality staff.
• Identify desired career path goals of staff and provide coaching and mentoring to aid the Quality staff in achievement of career goals.
• Prepare staff and co-hosts both internal and external audits.
• Collaborate with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames.
• Ensure that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff.
• Train cener Quality Assurance staff.
• Analyze tracking and trending data; determine appropriate actions to improve trending.

Skills And Qualifications

• BA in a relevant field, 1+ years of biologics industry experience, and 1+ year of QA-related work experience.
• ASQ certification is preferred.
• Strong knowledge of Microsoft Office suite.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 3472931123 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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