MCS Associate Quality Control

Job Title: MCS Associate Quality Control
Location: 100% Onsite, 91320, Thousand Oaks, CA
Duration: 1 Year (Possible Extension)
Shift: Monday-Friday, 8:00 AM - 5:00 PM
Overtime: Occasional (~once a month, typically 1 weekend day)

Job Description:
Under general supervision, this position will perform routine procedures and testing in support of the laboratory. Responsibilities include performing routine laboratory procedures, conducting analytical testing, and documenting, computing, compiling, interpreting, and entering data.
The role involves maintaining and operating specialized equipment, as well as initiating and/or implementing changes in controlled documents. The candidate must learn and comply with safety guidelines and cGMPs/CFRs, including maintaining training records, laboratory documentation, written procedures, building monitoring systems, and laboratory logbooks.

Key Responsibilities:

• Perform routine laboratory procedures and analytical testing
• Execute cell-based potency assays and ligand-binding assays (e.g., ELISA)
• Support stability studies including sample preparation, assay execution, and data analysis
• Document test results in compliance with GMP requirements and SOPs
• Prepare reagents, standards, and controls including pipetting and serial dilutions
• Maintain and monitor cell cultures to support assays
• Operate and maintain laboratory equipment including plate readers and automated liquid handling systems
• Manage inventory of reagents, reference standards, and lab supplies
• Support assay troubleshooting, investigations, and continuous improvement initiatives
• Collaborate with cross-functional teams to meet testing timelines

Top 3 Must Have Skill Sets:

• Proficiency in core laboratory techniques including pipetting, serial dilutions, and assay setup
• Working knowledge of QC/GMP practices including documentation, data integrity, and SOP adherence
• Hands-on experience with cell-based assays and/or ligand-binding assays

Basic Qualifications:

• High school/GED with 2 years of work or military experience OR
• Associate's degree with 6 months of work or military experience

Preferred Qualifications:

• Bachelor's degree in Life Sciences (Biology, Chemistry, Biochemistry)
• Lab and GMP experience in a regulated environment (pharma, biotech, or academia)
• Experience with analytical testing including cell-based potency assays and ELISA
• Proficiency in pipetting, serial dilutions, and automated liquid handling systems
• Basic proficiency in Excel and Word for data entry

Additional Skills:

• Ability to adhere to regulatory requirements, procedures, and safety guidelines
• Ability to evaluate documentation and data as per guidelines
• Strong organizational skills with ability to manage multiple priorities
• Strong written and verbal communication skills
• Detail-oriented with flexibility and adaptability
• Ability to understand when and how to escalate issues
• Ability to identify and implement improvements in routine tasks

Red Flags:

• Sloppy resume (typos, inconsistent formatting)
• Only academic experience
• No QC/GMP experience

Interview Process:

• Phone screen by manager
• In-person interview with team