Quality Control Associate I

We are seeking a QC Associate to support direct material (raw material) testing. As a Quality Control Associate I, you will be responsible for compendial method testing, direct material (raw material), reagent preparation, and sample management for biopharmaceutical products.  Additional responsibilities include equipment management and maintenance, and laboratory  duties. 

The Opportunity

• Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation).

• Core Compendial Testing: Execute and document routine and non-routine compendial testing, including pH, osmolality, Karl Fischer, basic wet chemistry, and other general techniques according to established procedures.

• Chemical Assay Execution: Perform specialized chemical assays and analysis, collect and process data, and ensure results are reported accurately and on time.

• Equipment Maintenance and Readiness: Perform daily and periodic laboratory equipment maintenance, including calibration and standardization of equipment, to ensure continuous readiness and compliance.

• Technical Support and Troubleshooting: Perform basic troubleshooting of chemical assays and provide initial support for instrument issues to minimize downtime.

• Materials and Inventory Management: Perform sample management and aliquoting. Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., preparing reagents).

• Investigation and Data Review: Assist in data trending and data review for conformance to specifications. Assist with or lead laboratory investigations OOS/OOT with appropriate oversight.

• Training and Cross-Functional Liaison: Train others in basic to complex laboratory and troubleshooting techniques. Serve as a liaison for daily activities and special projects within QC or cross-functionally.

• Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed

Who you are

• You possess a Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline with 3-4 years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.

Knowledge, Skills, and Abilities 

• Foundational Analytical Skills: Basic knowledge in Chromatography and chemical testing assays. Includes basic equipment troubleshooting techniques and proficiency in all necessary wet chemistry methods.

• GMP Execution & Compliance: Experience working in a GMP environment with the ability to read and follow Standard Operating Procedures precisely. Possesses knowledge of laboratory safety procedures and basic experience supporting quality events.

• Data & Systems Proficiency: Proficiency with laboratory electronic systems, including LIMS and Microsoft Office. Working knowledge of Empower or GSMP software is preferred.

• Agile Teamwork & Organization: Demonstrates excellent organizational skills and the ability to be agile and work independently in a fast-paced environment. Experience working on group projects and proficient in time management with oversight.

• Quality Mindset & Communication: Excellent interpersonal, written, and verbal communication skills. Possesses a continuous improvement mindset and basic experience supporting audit or inspection activities.

• Work in office and laboratory environments.

Physical & Work Environment Requirements

• Must be able to stand, walk, and use laboratory equipment for extended periods.

• Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE).

• Work is performed in a cGMP-regulated manufacturing facility.

• Work with analytical instruments that may involve exposure to hazardous chemicals  (corrosive, toxic, flammable, etc)

Travel may be up to 25% during start-up laboratory activities.   No more than 10% travel expected during routine operations.

  
Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $52,600 - $84,000 Annual.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link pro