Job Description: This position is focused on Microbiological assays. Experience in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred. Analyst would be a Senior Analyst responsible for ensuring routine testing is scheduled, completed, and reviewed within the required time frame. Analyst would be available for trouble shooting and to direct/coach junior analysts. Other responsibilities would include Standard Operating Procedure (SOP) revisions, qualification/validation support, as well as represent Quality Control (QC) Microbiology in meetings and during internal and regulatory audits. Analyst may be required to perform testing as needed for supporting lab functions. Job Responsibilities: Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending. Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation. Responsible for contributing to and/or handle laboratory investigations for events and OOS results including review. Performs testing as needed to support lab functions. Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes. Responsible for knowing, understanding and acting in accordance with Pfizer’s values. Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.) Performs tasks associated with maintaining current Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories. Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. Trains junior colleagues and may develop training plans and/or oversee training activities for groups. Job Requirements: Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets Non Standard Work Schedule, Travel or Environment Requirements Work schedule will be weekends Friday- Monday. 7a start time Intellectual capability to perform mathematical problems and perform data analysis. Physical or Mental Requirements Qualification & Experience: Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry Experience in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred MS Degree in Science/related field with 2 - 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry required Understanding of aseptic laboratory techniques and quality systems cGMP Laboratory experience preferred BS/BA Degree in Science/related field with 5 - 7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry required; OR Excellent effective written and verbal communication and interpersonal skills Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations Job Details: Company: Pfizer Vacancy Type: Full Time Job Location: Fayetteville, NC, US Application Deadline: N/A Apply Here vacanciesforyou.net
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