Aseptic Compliance Data Analyst

Pfizer • Rocky Mount, NC

1d • Onsite

About The Position

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: Provide oversight during execution of media fills, airflow visualization studies and other manufacturing activities. Perform necessary assessments of aseptic operation and update necessary documents. Accumulate key metrics for presentation to Management team, including gowning and aseptic technique observation. Author/revise the site Microbial Contamination Control Strategy plans as required. Author EM Quarterly and Annual Trend Reports Author ISO Data reports in support of facility ISO recertification. Compile, extrapolate, analyze and communicate data patterns within LIMS/MODA data. Provide Business Unit leadership data for trend reports, weekly excursion reports, quarterly SQRT meetings, audit requests and investigations. Track, close, and implement CAPAs Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing. Liaise with manufacturing, maintenance and aseptic trainers to appropriately schedule activities impacting the manufacturing areas.

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

Nice To Haves

• Experience at a manufacturing site.
• Managing and writing deviations
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities

Responsibilities

• Provide oversight during execution of media fills, airflow visualization studies and other manufacturing activities.
• Perform necessary assessments of aseptic operation and update necessary documents.
• Accumulate key metrics for presentation to Management team, including gowning and aseptic technique observation.
• Author/revise the site Microbial Contamination Control Strategy plans as required.
• Author EM Quarterly and Annual Trend Reports
• Author ISO Data reports in support of facility ISO recertification.
• Compile, extrapolate, analyze and communicate data patterns within LIMS/MODA data.
• Provide Business Unit leadership data for trend reports, weekly excursion reports, quarterly SQRT meetings, audit requests and investigations.
• Track, close, and implement CAPAs
• Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
• Liaise with manufacturing, maintenance and aseptic trainers to appropriately schedule activities impacting the manufacturing areas.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees