Senior Analyst, Analytical Quality Control
TalentBurst, Inc.
Newark, CA
Location: Newark CA
Duration: 12 months
Description: 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/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.
COMPETENCIES
Key Competencies:
· Integrity, Trust, Ethics & Values
· Results-oriented
· Strategic Skills
· Organizing/Priority Setting
· Business Acumen
· Planning
· Decision Quality
· Customer focused
· Interpersonal Savvy
· Problem Solving
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.”
· 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.
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About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!