QA Batch Review

Pfizer

8d

About The Position

Why Patients Need You 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. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies. Your work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Sole Quality Assurance review of the full manufacturing, packaging, and visual inspection records for completeness and acceptable results. Failure to perform could result in lot release delay and potential regulatory action. As each record is unique, attention to detail is highly important and the ability to identify issues within the unique records is a must. Once identified, the colleague will drive the level of criticality and resolution pathway of the issues. The reviews are performed to ensure completion and execution performed in accordance with document requirements, corrections appropriately addressed, calculations correct, specifications met and overall, the record is in adequate condition to support the Code of Federal Regulation requirements. Requires making decisions of the adequacy of documentation to meet regulatory requirements. If errors, inconsistencies, or deficiencies in documentation are noted, the reviewer is responsible for interaction with the respective business unit for follow-up and corrective action. Identify and assign corrections to responsible individuals. Assist in proper practice to address corrections to meet Good Documentation Practices. Set-up and maintain area batch related files. Enters and manipulates data in various software packages (Excel, Word, and others) for task correction and lot tracking purposes. Other Duties: Consistently communicates work sequence status to supervisor in a timely manner. Willing to learn and develop a career in the pharmaceutical industry. Actively participates in discussions to identify opportunities for correction, improvement and ways to complete work on time. Ensure safety, housekeeping, and compliance are maintained.

Requirements

• Applicant must have a 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.
• Requires competent oral and written communication, strong interpersonal skills, and decision-making skills.
• Requires making decisions of the adequacy of documentation to meet regulatory requirements.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Knowledge of production operations and analytical data records is preferred.
• Experience in parenteral drug product pharmaceutical manufacturing
• Demonstrate proficiency in computerized systems.

Responsibilities

• Quality Assurance review of the full manufacturing, packaging, and visual inspection records for completeness and acceptable results.
• Identify issues within the unique records.
• Drive the level of criticality and resolution pathway of the issues.
• Ensure completion and execution performed in accordance with document requirements, corrections appropriately addressed, calculations correct, specifications met and overall, the record is in adequate condition to support the Code of Federal Regulation requirements.
• Make decisions of the adequacy of documentation to meet regulatory requirements.
• Interaction with the respective business unit for follow-up and corrective action.
• Identify and assign corrections to responsible individuals.
• Assist in proper practice to address corrections to meet Good Documentation Practices.
• Set-up and maintain area batch related files.
• Enters and manipulates data in various software packages (Excel, Word, and others) for task correction and lot tracking purposes.
• Consistently communicates work sequence status to supervisor in a timely manner.
• Actively participates in discussions to identify opportunities for correction, improvement and ways to complete work on time.
• Ensure safety, housekeeping, and compliance are maintained.

Benefits

• eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies
• 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
• health benefits to include 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