Sr Associate, Pharm Science QA
Location:
San Francisco , California
Posted:
November 17, 2017
Reference:
280607897

ROLE SUMMARY Sr Associate (Pharm Sci QA) is responsible for Clinical Trial Material Batch release, GMP documentation review, support CMOs and QA point of contact for assigned Clinical Study projects. Sr Associate will report, escalate and make key quality decisions for the assigned project / studies. This position is located in San Francisco. ROLE RESPONSIBILITIES Perform batch releases for Clinical Trial Materials (CTM) Perform review of batch record and other GMP related documents as needed. Author and review of investigation reports for Discrepancies and CAPAs as required. Author and review of Change controls Compile, organize and file quality records and documentation which include but not limited to executed batch record documentation, manufacturing records, labeling and packaging records, and associated documentation. Compile and submit documentation required for QP releases as per the release schedules and priorities Provide Quality support for Contract Manufacturing vendors (CMOs) and communicate with CMOs and project team on key Quality communications and decisions. Timely escalation and reporting of issues and Quality metrics. Provide support for projects related to quality, manufacturing operational effectiveness, and cGMP compliance. Assist with intra-departmental quality improvement project activities Other QA responsibilities as assigned QUALIFICATIONS A Bachelor's degree in Science Experience Must have a minimum of 6 to 8 years' in GMP manufacturing and /or Quality environment Biotech/ Pharma experience preferred Experience in Quality systems like Trackwise is desirable Core Competencies, Knowledge and Skill Requirements PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Technical knowledge and hands on experience with GMP documentation review and procedures in a GMP environment. Experience working with Small Molecules/Biopharmaceuticals (CDER, FDA, EMA, MHRA) in a fast-pace environment. Knowledge of Global GMP regulations and guidelines. PHYSICAL/MENTAL REQUIREMENTS Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.) Ability to work on a computer for extended periods of time. Regularly required to sit for long periods of time, and occasionally stand and walk. Regularly required to use hands to operate computer and other office equipment. Close vision required for computer usage. Occasionally required to stoop, kneel, climb and lift up to 20 pounds NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS None EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Additional Offer Details: Last Date to Apply for Job: 11/21/2017 This job is Pfizer Exempt US Grade: 008 Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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