Quality Assurance 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

In this role, you will:

• Execute on defined and established procedures, work instructions and templates
• Process documents in electronic Document Management System
• Answer basic questions and send routine notifications
• Issue and reconcile batch records, forms, and logbooks
• Maintain and distribute documents to Controlled Document Locations
• Back-up the Records Management job function as required
• Responsible for receiving and logging GMP records, cataloging, physical or electronic filing, and retrieval as needed
• Works with GMP personnel submitting and retrieving records to ensure records are maintained and tracked in a compliant manner and are readily retrievable.
• Participates in cross-functional teams to implement, update, or upgrade systems or processes related to the management of GMP records.
• Supports GMP regulatory audits and inspections ensuring timely retrieval of both physical and electronic records.
• Scans and digitizes GMP records and verifies as true copies.
• Performed reconciliation of completed records issued for GMP activities.
• Collects and assists with reporting on relevant metrics.
• Works with off-site storage facilities to ensure compliant submission and retrieval of GMP records.
• Contribute to milestones related to specific projects.
• 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 3 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

Bonus Points If You Have (Preferred Requirements)

• Experience at a manufacturing site.
• Managing and writing deviations, Change Control and CAPA
• Experience in production batch record issuance, reconciliation, 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: On Premise

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,