QC Senior Lab Analyst
PfizerAbout the role
Why Patients Need You
The Senior Lab Analyst will independently conduct complex analyses, interpretation, and review of data on raw materials, in-process and finished drug products manufactured by Pfizer.
The Senior Lab Analyst will be responsible for the planning and implementation of method and instrument changes through development, tech transfers, project leadership, investigations, and change requests using cGMP. Position will act as a Subject Matter Expert (SME) interacting cross-functionally and writing supporting technical papers. Can troubleshoot complex methods and instruments and leads training of Lab Analyst I-III team members and is responsible for reviewing their work. The Senior Lab Analyst is also responsible for bench level scheduling of a group of analysts and or projects and accountable for the integrity of the resulting data.
How You Will Achieve It
Demonstrate technical / functional knowledge to coach, oversee, and set priorities for other Lab Analysts and coordinate with other teams on day-to-day activities for own applicable discipline using strong understanding of business operations.
Serve as Subject Matter Expert during technical discussions with regulatory professionals and regulatory inspectors.
Identify and make improvements to existing work processes / products within work team by applying ingenuity and taking appropriate risks.
Support multiple projects and complex on-going work activities within work team.
Solve complex problems within area of expertise.
Actively lead safety and continuous improvement initiatives.
Write investigations, and other highly technical documents.
Review and approve data generated by team members.
Represent Analytical Quality Control in cross functional and site product meetings. Support regulatory filings and interact with auditors during inspections.
Qualifications
Must-Have
Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school
diploma (or equivalent) and 6 years of relevant experience.Trained and proficient in multiple lab groups or previous pharmaceutical experience, for example bioburden, BET, sterility, bioassay, particulate investigation, or complex chromatography.
Excellent oral, written, and interpersonal communication skills with the ability to communicate obstacles and project status within functional group without prompting for updates.
Advanced math and instrument skills associated with scientific data analysis, processing, and interpretation with clear and valid conclusions.
Industry experience performing microbiological, chemical, and/or biochemical method development and validations utilizing the latest technologies including, but not limited to Spectroscopy, High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, ELISA, Western Blot, Slot Blot, microbial organism Identification.
PHYSICAL/MENTAL REQUIREMENTS
Considerable concentration and some manual dexterity.
Long periods of standing and sitting and significant walking.
Regular lifting (less than 35 lbs.) and reaching may be required to retrieve chemicals, reagents, and samples.
Extended time working at a computer
Maintains a clean and organized laboratory environment.
Strict documentation requirements.
Cooperates with other colleagues, departments, and sites.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require off-shift and weekends or may include on call work
Lab environment with hazardous chemicals and/or biologically active materials
Other Job Details:
Last day to apply: October 8th
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