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Pfizer · 20 hours ago

Aseptic Compliance Data Analyst

United States - North Carolina - Rocky Mount

Full-time

Onsite

Mid Level

$69K/yr - $111K/yr

4+ years exp

Pfizer is committed to delivering safe and effective products to patients, and they are seeking an Aseptic Compliance Data Analyst. In this role, you will provide oversight during manufacturing activities, analyze data patterns, and maintain compliance with aseptic manufacturing standards to improve patient outcomes.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

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

Qualification

Manufacturing PracticesPharmaceutical industry experienceData analysisQuality systemsEffective communicationTeamworkProblem-solvingTime management

Required

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