Senior Associate Quality Assurance (P

Company: Pfizer
Location: Groton
Posted on: April 4, 2021

Job Description:

This Quality Operations position will support the Global PSQA PharmSci Small Molecules QO department by performing Quality Assurance activities associated with the manufacture and testing of GMP clinical API, including disposition of product and ingoing materials, investigations, change control, SOPs and ensuring adherence to regulatory and internal compliance standards. The candidate will partner with key business lines to provide QA GMP guidance and support of clinical API manufacturing and testing operations. As a member of PSSM QO participate in the implementation of new initiatives and goals within PSQA, PSSM QO, and with business line partners (e.g. manufacturing, testing, etc.), to drive consistency, efficiency and compliance. This position requires an understanding of quality systems as they relate to the manufacturing and testing of API. The candidate should possess knowledge of cGMPs, and Pfizer quality processes and procedures for specific quality tasks and have a knowledge of scientific principles. Business travel may be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer. This position does not include the management of direct reports. ROLE RESPONSIBILITIES Perform disposition of clinical API, API intermediates, starting materials, raw materials, reagents in support of Groton API Manufacturing operations. Provide sound QA guidance to investigations of product/facility deviations. Use risk-management tools to assess quality issues occurring during manufacturing/testing activities. Contribute to the development and compliance of quality and business line partner procedures. Provide support to Inspection Readiness efforts, internal audits & regulatory inspections as needed. Continuously assess performance within area of responsibility against the Quality System Elements ORGANIZATIONAL RELATIONSHIPS This role is within the global Pharmaceutical Sciences QA group. Primary relationships with quality assurance team and the Pfizer business lines supported. Relationships with vendors (CMO's) and other Pfizer sites across the globe, as applicable. PREFERRED QUALIFICATIONS Bachelor's Degree (B.S.), preference in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience. 2-4 years of relevant work experience in GMP API manufacturing, testing and/or QA environment, experience with handling GMP compliance issues and investigations. Proficiency in computer systems, such as those supporting electronic document management, inventory management, investigations, LIMS, etc. Must possess strong written and oral communication skills as well as strong computer skills. Must exhibit strong interpersonal skills and the ability to work effectively in teams RESOURCES MANAGED N/A Supervision This role is a supervised individual contributor. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Business travel may be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer. OTHER DETAILS: Last day to apply: 4/16/2021 Employee Referral Bonus eligible 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. 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. Quality Assurance and Control#LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Keywords: Pfizer, Newton , Senior Associate Quality Assurance (P, Other , Groton, Massachusetts