Job Description
Location: Newark, CA 94560
Duration: 12 Months
The Senior Analyst in Analytical Quality Control ensures integrity and quality of drug substances and products by performing testing of raw materials, in-process samples, and finished goods using advanced laboratory techniques (e.g., ELISA, SDS-PAGE, Western Blot, HPLC). This role is responsible for accurate documentation of results, investigation of out-of-specification findings, equipment maintenance, and strict adherence to cGMP standards. We are looking for a Senior Quality Control Analyst with HPLC (preferably with biologics) experience to support our current portfolio and pipeline.
ESSENTIAL DUTIES
• Testing & Analysis: Performing and reviewing of chemical/bio-analytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance and drug products for release and stability programs.
• Data Integrity: Accurately record, analyze, and report results, identifying any deviations from specifications and procedures.
• Documentation: Write/review SOPs, protocols, assay worksheets, stability reports, and quality records such as laboratory investigations, deviations, CAPAs, and change controls.
• Compliance: Ensure the laboratory is in cGMP compliance with regulations (e.g., FDA and CDC), pharmacopeia standards, and established procedures.
• Equipment: Maintain laboratory space to regulatory expectations and internal procedures regularly, including support of equipment qualification and onsite vendor support.
• Troubleshooting: Conduct root cause analysis for quality issues and collaborate with cross-functional teams for resolutions.
• Inventory: Manage lab supplies and samples
• Safety and Training: Ensure a safe and secure laboratory environment, providing training to junior analysts on laboratory procedures and assays.
• Collaboration: Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development, to resolve quality issues and support process improvements.
Key Competencies:
WORK ENVIRONMENT & PHYSICAL DEMANDS This section of the job description is required by the Americans with Disabilities Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands of the job's essential duties. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”BASIC QUALIFICATIONS · Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline · 6+ years of regulated pharmaceutical industry experience · Must have experience with a range of biological and physicochemical methods. · Must have experience in peer-reviewing of Quality Control data. · Must have experience with a wide range of HPLC methodologies (CEX, SEC, RP-HPLC). · Experience with HPLC for peptides is a plus. PREFERRED QUALIFICATIONS · Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline · Experience with a range of biological and physicochemical methods (pH, ELISA, Western Blot, SDS-PAGE, HPLC) · Experience authoring and revising HPLC SOPs, HPLC methods, CR/DR/CAPAs, and technical writing · Proficient understanding of data integrity and ALCO+ principles · Effective written and verbal communication skills · Experience supporting analytical instrumentation calibrations (work orders, reports, etc.) with vendors a plus. | ||||||||||||
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 63.79/hr.