QA Associate - Operations Quality

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 involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
What You Will Achieve
This position is part of the PSSM (PharmSci Small Molecule) API Operations Quality team in Groton, CT. The candidates time will be split between support of the Quality Operations of GMP Clinical API Manufacturing role and support of documentation management activities.
The Quality Operations of GMP Clinical API Manufacturing role will support investigational product API manufacturing quality operations including the disposition of in-coming materials and batch record review as well as providing guidance to Manufacturing using risk-based decision making to assess quality issues occurring during API manufacturing. Documentation management responsibilities include end-to-end lifecycle of procedural documents and related controlled documents, document integrity, and support of the GMP document archive (Active Library).
Additionally, the candidate will participate in the implementation of new initiatives and goals within the quality team and with business line partners to drive consistency, efficiency, continuous improvement, and compliance. The candidate should possess sufficient knowledge of cGMPs.
In this role, you will:

• Perform disposition of raw materials, reagents and process aides in support of API Manufacturing operations.
• Perform API batch record review
• Gather information and recommend decisions within various work areas, seeks guidance and escalates as appropriate
• Use risk-management tools to assess quality issues occurring during API manufacturing and testing activities.
• Support documentation life cycle activities for procedures and support documentation archival activities.
• Provide support to Inspection Readiness efforts, internal audits, and regulatory inspections as needed
• May resolve simple to moderately complex problems, e.g., revise or improve a quality system feature
• Identify and implement process improvements to enhance procedural efficiency and compliance.
• Participate in cross-functional initiatives to support operational excellence.
• Offers approaches to and participates on teams for problem solving and guidance on routine tasks based on experience and information
• Contribute to QA by developing and introducing new processes/ideas and/or technologies that add value
• Identify opportunities and facilitate continuous improvement solutions to ensure consistency, compliance, and best practice sharing.
• Independently, manages own time to meet objectives
• Ensure operations and/or procedures are following regulations and Pfizer standards.
• Network internally to maintain effective business relationships with colleagues.

Here is What You Need
(Minimum Requirements)

• Applicant must have an associate's degree with 4+ years of experience, bachelor's degree with at least 2+ years of experience; OR a master's degree with more than 1 year of experience or high school diploma (or equivalent with 8 years of relevant experience.
• Experience in pharmaceutical manufacturing and/or Quality.
• Ability to handle multiple tasks concurrently and in a timely manner.
• Excellent written and verbal communication skills.
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and work independently in a fast-paced environment.

Bonus Points If You Have (Preferred Requirements)

• Experience with procedural systems and document management platforms.
• Familiarity with regulatory compliance standards (e.g., GxP, FDA, EMA).
• Prior experience supporting pharmaceutical or life sciences operations.
• Experience in 6 Sigma and/or LEAN Continuous Improvement programs

No relocation for this role
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $66,500.00 to $110,900.00. 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.
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.
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Quality Assurance and Control