What are the responsibilities and job description for the Quality Control Laboratory Analyst II position at Advanced Clinical?
Oceanside, CA - Onsite
Address: Oceanside, CA 92056
The Opportunity
We are seeking a QC Analyst II to join our client’s Quality Control team in Oceanside, CA. This position offers the opportunity to play a key role in ensuring the safety, efficacy, and compliance of products that make a meaningful impact on patients’ lives. The QC Analyst II will be directly involved in executing critical testing, maintaining regulatory compliance, and supporting process improvements within the laboratory environment.
You will collaborate with cross-functional teams in Quality, Manufacturing, and Regulatory to ensure laboratory operations meet Good Manufacturing Practice (GMP) standards and align with industry best practices.
Key Responsibilities
Address: Oceanside, CA 92056
The Opportunity
We are seeking a QC Analyst II to join our client’s Quality Control team in Oceanside, CA. This position offers the opportunity to play a key role in ensuring the safety, efficacy, and compliance of products that make a meaningful impact on patients’ lives. The QC Analyst II will be directly involved in executing critical testing, maintaining regulatory compliance, and supporting process improvements within the laboratory environment.
You will collaborate with cross-functional teams in Quality, Manufacturing, and Regulatory to ensure laboratory operations meet Good Manufacturing Practice (GMP) standards and align with industry best practices.
Key Responsibilities
- Perform a wide range of quality control testing on raw materials, in-process samples, and finished products, with a focus on BioAssays and/or Cell Culture techniques.
- Analyze and interpret results, identifying deviations and escalating issues in a timely manner.
- Ensure compliance with GMP regulations, SOPs, and other applicable standards.
- Maintain accurate and complete laboratory records, including test results, reports, and investigations, using appropriate documentation practices.
- Participate in troubleshooting, root cause analysis, and CAPA activities to support continuous improvement.
- Operate and maintain laboratory equipment, ensuring calibrations, qualifications, and preventative maintenance are up to date.
- Collaborate with internal stakeholders (Manufacturing, QA, and Regulatory teams) to ensure smooth handoff of testing data and results.
- Support inspection readiness activities and contribute to a culture of safety, quality, and compliance.
- 5-10 years of Quality Control laboratory experience in the pharmaceutical, biotechnology, or life sciences industry.
- Hands-on expertise in BioAssay or Cell Culture testing (required).
- Strong problem-solving skills with a high level of attention to detail.
- Excellent written and verbal communication skills; ability to document results clearly and concisely.
- Solid knowledge of industry best practices in quality control and regulated laboratory environments.
- Prior experience with laboratory GMP testing and familiarity with FDA/ICH guidelines.
- Experience working in a fast-paced, collaborative, and regulated environment.
- Ability to adapt to changing priorities and contribute to team success.
