Job Title: Senior Quality Control Analyst (Pharmaceuticals)
Role Overview
We are seeking a highly skilled Senior Quality Control Analyst to join our laboratory operations team. In this role, you will perform critical analytical testing for incoming raw materials, in-process samples, and final products to ensure the highest standards of safety and efficacy. You will be responsible for executing complex chromatography and wet chemistry assays while maintaining the validated state of the laboratory through instrument calibration and audit readiness. The ideal candidate is a disciplined scientist with deep experience in a GMP-regulated environment and a strong command of analytical troubleshooting.
Key Responsibilities
โข Analytical Testing: Execute testing for raw materials, stability samples, and finished products using precision equipment, including balances, pH meters, UV/Vis spectrophotometers, and TOC analyzers.
โข Advanced Chromatography: Perform high-level chromatography (HPLC and GC) following extensive site-specific qualification and training.
โข Laboratory Governance: Oversee general laboratory maintenance, housekeeping, and instrument calibration routines to ensure constant audit readiness.
โข Data Review & Reporting: Assist management in the review of QC data, providing summaries and technical reports that interpret complex analytical results.
โข Investigations & Compliance: Support QC Management in conducting Out-of-Specification (OOS) investigations, deviations, and CAPAs using data-driven fact-finding.
โข Logistics & Coordination: Manage sample receipt, processing, and distribution for both internal and external laboratory testing, ensuring accurate tracking and result closure.
โข Environmental Monitoring: Regularly perform water sample collection and testing in accordance with site environmental protocols.
Qualifications & Requirements
โข Education: Bachelor's Degree in Chemistry or a closely related scientific field is required.
โข Experience: * Minimum of 5+ years of professional experience in a Pharmaceutical Quality Control environment.
โข Proven expertise in testing APIs (Active Pharmaceutical Ingredients) and/or Finished Dosages.
โข Technical Mastery:
โข Must have working knowledge of HPLC and GC systems.
โข Strong understanding of FDA GMPs (21 CFR 211, 820, and/or 600); ISO 9001/13485 is a plus.
โข Proficiency in advanced mathematical concepts (ANOVA, correlation techniques, sampling theory) and statistical analysis.
โข Physical Requirements: Ability to stand/walk for extended periods, lift up to 50 lbs, and work in a lab environment requiring manual dexterity and close vision focus.
Equal Opportunity Employer / Disabled / Protected Veterans
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https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Nichols
Branch Phone:
(909) 244-1777
Location:
Ontario, CA