Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

The position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation / QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Leads triage using trend activities. The role might need to act independently to help identify process improvement and facilitate the implementation.

What You Will Achieve

In this role, you will:

• Work to develop and implement quality assurance procedures and guidelines to support the Quality Control team’s testing and evaluation efforts.

• Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.

• Provide final QA approval on more complex change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.

• May also review and approve Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build Master Batch, or any electronic record when needed, and all associated with compendial changes.

• Drives compliance, efficiency, and process improvement projects.

• Capable to make complex quality decisions in real time according to regulations and procedures.

• Interfaces with internal partners to resolve technical issues.

• Perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.

• Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.

• Approve investigations and change control activities to maintain compliance with configuration management policies.

• Contribute to moderately complex projects, managing time effectively and developing short-term work plans.

• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.

• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Here Is What You Need (Minimum Requirements)

• BA/BS degree in Biology, Chemistry, Micro and Bioanalytical with 2+ years of experience OR MBA/MS degree in Biology, Chemistry, Micro and Bioanalytical with any years of relevant experience OR Associate’s degree with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of experience.

• Experience in Quality Control Laboratory (e.g., transfer, equipment qualification, analytical testing, stability, etc.) cGMP’s Laboratory environment (Pharmaceutical industry)

• Familiarized and experience in Pharmacopeia requirements (e.g., USP, JP, EMEA amongst others)

• Experience or familiarized with Data Integrity requirements

• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards

• Strong critical thinking skills, problem solving and analytical skills

• Attention to detail and ability to work independently

• Ability to work effectively within own team and interdepartmental teams

• Good working knowledge of Microsoft Excel and Word

• Provide excellent communication writing and analytical skills

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems

• Strong organizational skills and attention to detail

• Experience with regulatory compliance and documentation

• Ability to mentor and review the work of other colleagues

• Proven ability work in a team environment through conflict resolution and negotiation

Physical/Mental requirements

• Ability to work in a fast-paced, dynamic environment

• 50% on the floor time (walking/standing)

• Able to manage different priorities

• Occasionally lift and or move object up to 30 pounds

• Stand / walk during the entire length of the