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US-CA-Tustin: QA Manager in Biotech

Date: 19-Jul-2011
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QA Manager in Biotech

Manage batch release activities including BPR review, test results review, timely correction of observations noted during review, closure of all deviations and other exceptions associated with the batch, preparation of batch disposition and certification of analysis. Assist during FDA, CBER, Team Biologics, Foreign and/or Client audits and to escort auditors/inspectors when they visit the manufacturing facility. Oversee external audits of critical and major vendors for adherence to GMPs and other relevant Federal, foreign and corporate regulations and policies. Oversee external audits of contract manufacturers, contract service providers and suppliers, for compliance with policies relevant to Good Manufacturing Practices and Good Laboratory Practices. Oversee independent commitment verification audits of actions taken to correct audit observations to assure completion and adequacy of the commitment to meet FDA and other relevant Federal, foreign and corporate regulations and policies.

Oversee a team of Quality Assurance personnel.

Establish Quality Improvement for all QA processes.

Prepare coordinate and schedule tasks and set objectives for QA personnel

Recruit, train, develop, support and motivate QA personnel

Review document revisions and updates. These documents include company SOPs, Test Methods, Formulation Methods, Raw Material Specifications, Batch Production Records and related forms. These are updated periodically to assure cGMP compliance.

Coordinate timely implementation of CAPAs

Prepare Annual Product Quality Reviews for clinical and commercial products manufactured by company.

Prepare annual regulatory updates for INDs and NDAs.

Establish measures for product and process quality and provide department head with status reports of all studies, projects, and department activities.

Prepare reports on product quality audits

Establish a structured and demonstrated system of procedures ensuring that activities, products, and services conform to requirements.

Plan systematic activities that are necessary to provide adequate confidence that the product or service will meet the given requirements.

Participate in assessments of ongoing QA activities and provide input as needed to maintain and/ or improve upon compliance issues.

Education and/or Experience

A bachelor's degree in life/physical science such as chemistry, biology, microbiology, pharmacy, biochemistry, with 10+ years of experience manufacturing, QC lab, Regulatory or QA functions in a pharmaceutical, biologics or sterile products manufacturing facility with the ability to demonstrate knowledge of GMP's.

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BioTech FYI Center