Andover, Massachusetts, United States
Onsite
Not Available
Use Your Power for Purpose
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will be responsible for providing Quality Assurance support to GMP clinical manufacturing. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations to ensure compliance.
As an associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate explaining issues and create a collaborative team environment.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
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 escalate 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)
Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of 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 reg ulations 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 www.pfizer.com/careers 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 disabilityrecruitment@pfizer.com. 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
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