Senior QA Specialist
Medivation, Inc. - San Francisco, CA

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Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Senior QA Specialist, reporting to the Associate Director, GMP QA.

Job Duties

Essential duties & responsibilities but not limited to the following:
  • Perform batch record review activities for products ensuring products meet specifications and are produced and tested in compliance with approved procedures and applicable regulations
  • Compile, organize and file quality records and documentation which include but not limited to executed batch record documentation, manufacturing records, analytical data package, and labeling and packaging records, and associated documentation
  • Review analytical data and trend, as required
  • Generate key quality performance indicators, collect metrics and perform data trending analysis
  • Participate and support internal audits, external audits and regulatory inspections, as required
  • Assist in Quality Investigations of GMP activities, Generate Incident Reports, Change Controls and CAPA reports
  • Develop and revise Standard Operating Procedures, specifications, validation procedures, work instructions and forms as needed
  • Develop and implement methods and procedures for monitoring work activities Special project as required supporting departmental goals
  • Perform other duties as assigned
Requirements: .
  • Ability to work in a fast-paced environment, willing and eager to work in a hands-on capacity is required
  • Must have a minimum of 6 years biopharmaceutical experience with small molecules, preferably oral solid dosage
  • The ability to collaborate successfully and build relationships with internal teams, suppliers and agencies is required
  • Must have strong computer skills, Microsoft office programs (Word, Excel, PowerPoint, Outlook, etc
Education
  • Bachelor's degree is required

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Employment Opportunity, M/F/D/V