Quality Assurance Supervisor job in Chicago, USA

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Assurance Supervisor for a biopharmaceutical company located in Chicago, IL. Successful candidate will be responsible for the overall quality program of the Donor Center.

Job Responsibilities:

Determine if quality activities and manufacturing records are in compliance with SOPs and regulatory requirements; determine the need for corrective actions; ensure proper documentation and determines effectiveness of the action.
Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
Perform regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing storage and shipping.
Provides direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames
Identifies desired career path goals of the Quality staff and provides coaching and mentoring to aid the Quality staff in achievement of career goals
Prepares staff and co-hosts both internal and external audits
Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames
Ensures that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff
Obtains certification as a Quality Trainer; responsible for training of center Quality Assurance staff
Analyze tracking and trending data; determines appropriate actions to improve trending

Skills and Requirements:

1+ work experience in the biologics industry, preferably in a donor center, and 1+ year quality assurance-related work experience
Supervisory experience preferred
Must possess knowledge and aptitude to learn various computer software; such as word processing, spreadsheets or other related software programs
Must have adequate communication skills and be able to effectively communicate with people at all levels
Must have ability to make decisions impacting the product and donor safety based on independent judgment and discretion

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 Brandy Plum at (+1) 646-367-2745 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.

Proclinical Staffing is an equal opportunity employer.

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