Senior Analyst, Analytical Quality Control

Title:

Sr. QC Analyst

Location:

Newark, CA

Duration: 12 months

This 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 experience (preferably with biologics) to support our current portfolio and pipeline.

• Testing & Analysis:
  Performing and reviewing of chemical/bioanalytical 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:

• Integrity, Trust, Ethics & Values
• Results‑oriented
• Strategic Skills
• Organizing/Priority Setting
• Business Acumen
• Planning
• Decision Quality
• Customer focused
• Interpersonal Savvy
• Problem Solving

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."

• Laboratory-based role requiring daily use of PE, including lab coats, safety glasses, and gloves.
• Routine standing, walking, bending, lifting to 25 lbs., and handling chemical reagents and laboratory materials.
• Work involves exposure to chemical substances, solvents, potent compounds, and analytical instrumentation in a controlled laboratory setting.