Quality Assurance Specialist

Pfizer; United States; Sur place; USD 69 000 - 114 000; Plein temps

Avantages offerts par ce poste

Relocation support

Comprehensive benefits

Résumé du poste

Pfizer is seeking a Quality Assurance professional for our penicillin manufacturing facility in the United States. The role focuses on evaluating clinical and commercial drug batches, ensuring documents meet specs, and maintaining cGMP compliance.

This first-shift, on-site position offers relocation support and a robust benefits package, including health, retirement plans, and paid time off. You will collaborate across manufacturing and QA teams to detect deviations, approve investigations, and

Qualifications

• Pharmaceutical industry experience and quality systems knowledge.
• Solid knowledge of current Good Manufacturing Practices (GxP).
• Ability to work effectively in cross-functional teams and communicate clearly.

Responsabilités

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Ensure documents meet specifications through sampling and statistical process control.
• Identify and address deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Maintain inspection readiness and support regulatory and customer inspections.

Connaissances

Quality systems

GxP knowledge

Teamwork

Communication

Problem-solving

Manufacturing experience

Formation

Bachelor's degree

Associate's degree +4 years relevant experience

High school diploma +6 years relevant experience

Outils

ERP system

Description du poste

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:

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Ensure product and process documents meet established specifications through rigorous sampling and statistical process control.
• Identify and address deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities to maintain compliance with configuration management policies.
• 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.

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

Bonus Points If You Have (Preferred Requirements)

• Experience at a 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
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

PHYSICAL/MENTAL REQUIREMENTS

Expected to spend time between office and shop floor as needed to support manufacturing.
This is a penicillin manufacturing facility. Any candidates applying must NOT be allergic to penicillin.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a first shift position (0700-1530). The selected candidate will be required to support manufacturing as needed and be on premise for occasional weekend shifts.

Relocation support available

Work Location Assignment: On Premise

The annual base salary for this position ranges from $68,600.00 to $114,300.00. 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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. Subj