Job Description

Job Title: QC Chemistry Associate

Location: Irvine, CA

Schedule: Monday–Friday, 8:00 AM – 5:00 PM (some weekend OT may be requested, not mandatory)

Pay: Up to $29

Duration: 1-year contract with the possibility of extension

Start Date: ASAP

Interview Format: In-person preferred; flexible

Position Summary:

We are seeking a QC Chemistry Associate to support both new projects and routine quality control operations. The successful candidate will perform qualitative and quantitative analyses of compounded admixed pharmaceutical products to ensure product quality and regulatory compliance. This individual will work under cGMP/GLP guidelines, perform a variety of chemical testing techniques, and support investigations related to product performance, process deviations, and customer complaints.

This is an excellent opportunity for an analytical chemist with at least 1 year of lab experience to work in a dynamic, fast-paced pharmaceutical quality environment. Candidates with more experience may be considered for a higher-level opportunity.

Key Responsibilities:

• Perform routine and non-routine chemical analyses using UPLC, HPLC, ICP-MS, GC-MS, and wet chemistry techniques.
• Support method development and validation activities under guidance from senior chemists.
• Analyze product potency, raw materials, and environmental samples in accordance with specifications and SOPs.
• Assist in investigations related to product complaints, non-conformances, and process deviations.
• Conduct and document technical experiments, trend analyses, and chemistry reports for management review.
• Review analytical data, chromatograms, and test results to ensure compliance with cGMP standards.
• Prepare standards, reagents, and maintain lab instrumentation, including troubleshooting and basic maintenance.
• Maintain accurate, detailed, and compliant documentation in accordance with 21 CFR Part 11.
• Participate in internal and external audits (FDA, BOP, DEA) and support audit readiness efforts.
• Practice and demonstrate aseptic techniques and safety compliance in the lab.

Qualifications:

Required:

• Bachelor’s degree in Chemistry or a related field.
• Minimum of 1–2 years of laboratory experience (pharmaceutical, compounding, or medical device preferred).
• Hands-on experience with chromatography (e.g. UPLC, HPLC) and basic chemistry instrumentation (e.g. pH meter, titration).
• Familiarity with cGMP, GLP, USP, and FDA regulatory requirements.

Preferred:

• Experience in statistical data analysis and trend reporting.
• Knowledge of UPLC, HPLC, GC/MS, ICP/MS, HLPC/MS techniques.
• Experience supporting investigations, CAPAs, and regulatory documentation.

Skills & Competencies:

• Strong analytical and problem-solving abilities.
• Ability to interpret technical data and troubleshoot instrumentation issues.
• Effective verbal and written communication skills.
• High attention to detail, accuracy, and documentation.
• Capable of working independently and within a team.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and data analysis software.

Work Environment & Physical Demands:

• Work performed in a laboratory setting with controlled environments and use of PPE.
• Ability to sit or stand for long periods and perform repetitive tasks.
• Ability to lift or move up to 40 lbs.
• Occasional travel or weekend work may be requested.

Additional Information:

• One position currently open, with the possibility of a second pending internal transfer.
• Role may include both project-based and routine QC responsibilities.
• Contractor will support analytical testing to free internal resources for new initiatives.

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