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 customeroriented culture is rooted in science and riskbased 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 offsite 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 crossfunctional 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 supervisors 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 realtime 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)

• Bachelors degree with any years of experience or an Associates 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 ones own team and interdepartmental teams

• Effective written and oral communication skills

• Ability tomanage daytoday 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 nonconformance root cause analysis and change control management

• Strong problemsolving skills

• Ability to work independently and as part of a team

• Excellent time management and multitasking abilities

PHYSICAL/MENTAL REQUIREMENTS

N/A

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A
Work Location Assignment:Hybrid

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 $58500.00 to $97500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 . 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.

Quality Assurance and Control

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