QA Associate

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes. What You Will Achieve Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team. Review and approve various Good Manufacturing Practices {also cGMP} records (primarily batch records for Drug substance and Drug Product) and investigations. Review/Approve Standard Operating Procedures (SOPs) revisions and Validation Documentation (Periodic Reviews). Ensure that all documents for batch release are reviewed for completeness and accuracy. Make Quality decision to resolve moderately complex issues with assistance from management/Sr. Staff. Seek out and assess internal and external compliance with applicable regulations. Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed. Recognize when an issue is beyond your sphere of influence and elevate immediately. Participate in Limited Duration Teams, Continuous Improvement (CI) projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate. Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations. Help to define appropriate action plans for improvement and follow-up and communicate action closures. May participate in the release of raw materials, as needed. Procedural Administration/Active Library Support as needed. Here Is What You Need (Minimum Requirements) Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience. Experience in pharmaceutical industry. Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. Ability to work in a team environment within own team and interdepartmental teams. Excellent communication and interpersonal skills. Proactive approach and strong critical thinking skills. Effective written and oral communication skills. Experience with Digital Applications /Solutions (Co-Pilot, AI applications, eBR, etc). Bonus Points If You Have (Preferred Requirements) Experience at a manufacturing site. Experience of writing and managing deviations. Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management is preferred. PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle a large quantity and broad scope of different types of quality assurance work. Ability to work independently, problem solve and make recommendations for solutions. Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting. Able to lead and/or participate in person or Microsoft Teams meetings. Work Location Assignment: On Premise The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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. 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. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email View email address on click.appcast.io. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control De carrières van Pfizer zijn uniek. In onze cultuur van individuele eigenaarschap geloven we in ons vermogen om de toekomst van de gezondheidszorg te verbeteren en in ons potentieel om miljoenen levens te transformeren. We zijn op zoek naar nieuw talent om lid te worden van onze wereldwijde gemeenschap, om nieuwe innovatieve therapieën te ontrafelen die van de wereld een gezondere plek maken. #J-18808-Ljbffr Pfizer