Quality Assurance Associate II

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.
The QA Associate II is responsible for performing day to day activities related to Quality Document Control (QDC) and GMP Records filing systems for both physical and electronic records. QDC will own and manage the GMP Quality business processes supporting Quality Document Control authoring, review, approval, and archive of GMP lifecycle documents.
What You Will Achieve
In this role, you will:

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Issue and reconcile GMP forms and logbooks.
• Execute on defined and established procedures, work instructions and templates.
• Process documents in Electronic Document Management System (EDMS).
• Maintain and distribute documents to Controlled Document Locations (CDLs)
• Identify and address deviations from manufacturing and packaging standards.
• Manage the Records Management Job function, archiving and off-site storage process.
• Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed.
• Work with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in compliant manner and are readily available.
• Scans and digitizes GMP records and verifies as true copies.
• Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records. Collects and assists with reporting on relevant metrics.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Learn and apply basic team effectiveness skills within the immediate work team.
• Make decisions within limited options to resolve basic problems under supervisor's direction.
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
• Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems.
• Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.
• Participates in continual improvement activities within Document Control and GMP Records management.

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 the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
• Effective written and oral communication skills
• Ability to manage day-to-day workload with minimal oversight
• Basic knowledge of continuous improvement principles and practices
• Excellent written and oral communication skills
• Highly organized and detail oriented

Bonus Points If You Have (Preferred Requirements)

• Experience at a cGMP manufacturing site.
• Managing and writing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities

PHYSICAL/MENTAL REQUIREMENTS
N/A
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
N/A
Work Location Assignment: Onsite
OTHER JOB DETAILS
Last Date to Apply for Job: April 21, 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
The annual base salary for this position ranges from $58 500,00 to $97 500,00. 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.
Quality Assurance and Control
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