Quality Assurance Specialist jobs in San Francisco, CA

Description:

Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR.

 Perform review/release of executed batch records.

 Perform review/approval of various packaging documents as it applies to CXO (Contract Manufacturing /Packaging Organization.

 Interface with CXO in support of routine manufacturing/packaging activities.

 Performs a variety of activities to ensure compliance with applicable regulatory requirements.

 Adhere to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

 Reviews manufacturing/packaging control data for in process and finished products.

 Review and provide information relevant to manufacturing/packaging of product at the CXO for the writing of the annual product reviews.

 May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured/packaged products.

 Works with cross-functional teams during new product start-ups and product launches and identifies checkpoints for new products and processes.

 Normally receives very little instruction on routine work, general instructions on new assignments.

Skills:

Quality assurance, Gmp, Batch record, Capa, Batch record review

Qualifications:

Specific product knowledge: Pharma products in general, finished goods – not API. This is a packaging review – a lot of common sense or dealing with complex biologics. Reviewing labeling.

 Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

 Demonstrates working knowledge of quality assurance systems, methods and procedures.

 Demonstrates knowledge of FDA / EMEA standards and quality systems.

 Demonstrates basic knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.

 Demonstrates audit and investigation skills, and report writing skills.

 Demonstrates good verbal, written, and interpersonal communication skills.

 Demonstrates working proficiency in Microsoft Office applications.

Education and Experience

 4 years of relevant experience in a GMP environment related field and a BS.

 2 years of relevant experience and a MS.

 Prior experience in pharmaceutical industry is preferred.

Experience Level:

Intermediate Level

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