QC Expert – Chemistry / Microbiology

QC Expert – Chemistry / Microbiology

Location: Carlsbad, CA – 100% onsite
Duration: 6 months
Shift Schedule: 8:00 AM–8:00 PM, either Sunday–Tuesday and every other Wednesday, or every other Wednesday and Thursday–Saturday.
Note: Periodic mandatory overtime may be required.

Job Purpose

The QC Expert will perform and review laboratory testing of materials and products in accordance with established Standard Operating Procedures (SOPs), analytical methods, current compendial requirements, and cGMP standards. The role supports analytical release, microbiological quality control, data integrity, and site qualification and validation activities.

Key Responsibilities

• Perform and review analytical testing in compliance with cGMP requirements and established laboratory procedures.
• Review and approve analytical data and test results for product and material release, as applicable.
• Perform or support HPLC/UPLC testing; experience with Empower software is preferred.
• Conduct microbiological testing of materials, utilities, environmental samples, and personnel monitoring samples.
• Support site qualification, validation, sample planning, and sampling execution activities.
• Maintain accurate laboratory records and ensure data integrity throughout the testing process.
• Investigate testing discrepancies and support the identification and resolution of out-of-specification (OOS) results.
• Complete all required training and documentation within established timelines.
• Report technical complaints, adverse events, and special-case scenarios related to client products within the required 24-hour timeframe.
• Follow applicable quality management systems, laboratory safety procedures, and regulatory requirements.

Required Qualifications

• Bachelor's degree in Chemistry, Microbiology, Life Sciences, or a related discipline.
• 3–5 years of experience in a GMP testing laboratory.
• Strong knowledge of cGMP, quality control, quality management systems, and laboratory documentation.
• Experience with analytical testing and/or QC microbiology.
• Understanding of data integrity, quality compliance, and laboratory best practices.
• Strong problem-solving and communication skills.
• Prior pharma or life sciences experience is required.
• Local candidates in the Carlsbad/San Diego area who can work onsite and accommodate the shift schedule are preferred.

Key Performance Expectations

• Complete mandatory training on time.
• Perform testing and document results accurately and in compliance with GMP requirements.
• Minimize testing errors and OOS events through strong laboratory practices and data integrity controls.