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US: Quality Assurance Supervisor in Biotech

Date: 08-Nov-2011
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Quality Assurance Supervisor

∑ Performs final QA review and release for all product shipments and associated documents, to ensure shipment meets customer specifications.

∑ Performs regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing, storage and shipping.

∑ Conducts regularly scheduled staff meetings with respective Quality staff.

∑ Determines and prepares work schedules of the Quality staff to ensure adequate center coverage.

∑ 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.

∑ Writes and presents performance reviews to Quality staff. Delivers corrective/disciplinary action and termination when Quality staff performance is inadequate.

Analyzes tracking and trending data, determine appropriate actions to improve trending.


∑ Bachelor's degree in applicable field of study preferred. Equivalent combination of education and job experience may be considered. ∑ ASQ certification preferred. ∑ Supervisory experience preferred. ∑ Must have a minimum of one (1) year work experience in the biologics industry, preferably in a donor center, and a minimum of one (1) year work quality assurance related experience. ∑ Must have legible handwriting. ∑ 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 of all levels. ∑ Must have excellent organizational skills and must be detail-oriented. ∑ Ability to interpret SOPís and regulatory requirements. ∑ Ability to make decisions impacting the product and donor safety based on independent judgment and discretion.

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