QC Chemistry Associate

Job Title: QC Chemistry Associate I

Location: Irvine, CA

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

Type: 1-Year Contract (possibility of extension)

Pay: Up to $27.58

Start Date: ASAP

Interview Format: In-person preferred; flexible

Position Summary:

We are seeking a QC Chemistry Associate I to join our Quality Control team. The successful candidate will perform routine quantitative and qualitative chemical analyses of compounded admixed pharmaceutical products distributed to healthcare facilities nationwide. This position plays a key role in ensuring product quality and regulatory compliance by conducting laboratory tests, maintaining instruments, and following cGMP and GLP protocols.

This role will primarily support routine lab operations, but may also contribute to project-based activities as needed. Candidates with more experience may be considered for a higher-level QC Chemistry Associate II role.

Key Responsibilities:

• Perform routine laboratory analyses on raw materials, in-process samples, and finished products in accordance with written procedures.

• Conduct wet chemistry tests such as pH, specific gravity, titrations, and viscosity measurements.

• Operate and maintain laboratory instrumentation including UPLC, HPLC, and basic analytical tools (e.g., pH meters).

• Standardize reagents and prepare solutions following established SOPs.

• Troubleshoot and report any equipment malfunctions promptly.

• Ensure all activities comply with cGMP, GLP, USP, FDA regulations, and internal SOPs.

• Accurately document results and compile data for batch release and investigations.

• Participate in the review of analytical data and ensure compliance with specifications.

• Support investigations of test failures, non-conformances, and out-of-specification results.

• Maintain cleanliness and organization of laboratory workspaces and follow safe waste disposal procedures.

• Support internal and external audits as needed.

• Exhibit professional behavior consistent with company values in all interactions.

Qualifications:

Required:

• Bachelor's degree in Chemistry, Biochemistry, or a related Life Sciences discipline.

• Minimum of 1 year of hands-on experience in a laboratory or quality control setting.

• Familiarity with basic laboratory techniques and instruments, including pH meters and wet chemistry procedures.

• Ability to follow detailed instructions accurately and consistently.

• Strong organizational and communication skills.

Preferred:

• Experience working in a regulated environment (pharmaceutical, compounding pharmacy, medical device).

• Exposure to chromatographic techniques (e.g., UPLC, HPLC).

• Knowledge of FDA, USP, cGMP, GLP, and 21 CFR Part 11 requirements.

Skills & Competencies:

• Strong attention to detail and documentation accuracy.

• Ability to manage multiple tasks and prioritize effectively.

• Competent in Microsoft Office (Word, Excel, PowerPoint).

• Effective verbal and written communication skills.

• Strong problem-solving abilities and team collaboration mindset.

Physical Demands:

• Ability to stand and/or sit for extended periods.

• Ability to perform repetitive tasks and lift/push/pull up to 40 lbs.

• May require occasional travel.

Work Environment:

• Indoor laboratory setting with controlled temperature and noise levels.

• Regular use of personal protective equipment (PPE).

Additional Notes:

• Initially hiring for one opening, with potential for a second depending on internal staffing decisions.

• The role will support both routine QC testing and may assist with new projects.

• This position is critical to maintaining quality and compliance for compounded pharmaceutical products.

The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee.

The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off.

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