Sr. Associate Scientist - Bioanalytical
Pfizer
Full-time
On-site
North Carolina, United States
Operations
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Role Summary
Sr. Associate Scientist - Bioanalytical
Responsibilities
- Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.
- Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records.
- Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories.
- Support ELISA, plate-based, along with other relevant analytical testing and conduct QC Analytical related investigations.
- Perform testing on various samples, manage Laboratory Information Management System builds, and review laboratory data.
- Serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and train junior colleagues.
Qualifications
- Required: 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
- Required: Strong technical skills in method validation and QC testing
- Required: Experience in QC analytical testing preferably in ELISA and plate-based testing
- Required: Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
- Required: Detail-oriented with robust knowledge of quality systems
- Required: Familiarity with research unit clinical and analytical laboratory environments
Skills
- Proficiency in ELISA and plate-based analytical testing
- Laboratory Information Management Systems (LIMS) familiarity
- Data analysis and interpretation
- Regulatory requirements and guidelines knowledge
- Mentoring and training junior colleagues
Education
- Bachelor's degree or equivalent in a relevant field; or Associate's degree with years of experience; or high school diploma with significant relevant experience
Additional Requirements
- Physical/Mental Requirements: Ability to lift 30 lbs, stand 3–4 hours, sit 2–3 hours, walk long distances, and bend to access items; strong mathematical and data analysis capabilities; effective communication and time management
- Non-Standard Work Schedule: First shift (8:00 am to 4:30 pm) with potential for weekdays/weekends as needed; minimal off-shift work