QA Specialist

The QA Specialist utilizes technical training and demonstrates skills in a cGMP environment. The individual will apply Quality concepts to ensure drug substance is reviewed and dispositioned appropriately. Duties will include:
Main focus of the position will be project management for batch record review, document review, investigation review, process change control review and disposition activities between Wyeth and Genentech including coordinating comment resolution for these activities.
Act as liaison for PPU B QA Operations with PPU A QA Operations for site QA initiatives, maintain reports and prepare PPU B QA Ops presentations for internal and joint Wyeth/Genentech meetings.
May have some batch record, investigation, and/or change control review responsibilities and/or disposition responsibilities; also review of SOPs, technical reports, protocols, final reports, PTRs, and other forms of documentation as required.
Develop systems and procedures to facilitate compliance activities.
Participate in or direct compliance Teams. Is expected to make decisions in cross functional meetings.
May have direct responsibility of functional area or project.
Ensure that the Quality Unit and Wyeth BioPharma compliance standards are met throughout the company.
Interpret and relay QA policies to others within Wyeth BioPharma. Represents QA at meetings.
Participate in internal and external audit programs as required.
Some travel may be required.BS/BA degree with at least four to seven years experience in a related field.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at