QA Batch Review

Pfizer

104d • $22 - $38

About The Position

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

Requirements

• High School Diploma (or Equivalent) and 6 years of relevant experience OR an associate degree with 4 years of experience OR a bachelor's degree with 0+ years of experience.
• Strong attention to detail.
• Experience with Good Documentation Practices either through completion of documentation or review.
• Competent oral and written communication skills.
• Strong interpersonal skills and decision-making skills.
• Knowledge of production operations and analytical data records is preferred.

Nice To Haves

• Experience in parenteral drug product pharmaceutical manufacturing.
• Demonstrate proficiency in computerized systems.

Responsibilities

• Evaluate and review Pfizer’s clinical and commercial batches of drugs.
• Ensure that product and process documents match the specifications based on established sampling and statistical process control procedures.
• Identify deviations from established standards in the manufacturing and packaging of products.
• Approve investigations and change control activities to ensure compliance with configuration management policies.
• Drive the level of criticality and resolution pathway of identified issues.
• Perform Sole Quality Assurance review of the full manufacturing, packaging, and visual inspection records for completeness and acceptable results.
• Ensure completion and execution performed in accordance with document requirements.
• Interact with the respective business unit for follow-up and corrective action on documentation errors.
• Assist in proper practice to address corrections to meet Good Documentation Practices.
• Set-up and maintain area batch related files.
• Enter and manipulate data in various software packages (Excel, Word, etc.) for task correction and lot tracking purposes.
• Communicate work sequence status to supervisor in a timely manner.
• Actively participate in discussions to identify opportunities for correction and improvement.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees