Job ID: 1802694
Reference Code: JL-Quality-Control Analyst III
Job Summary
A direct hire opportunity is available for a Quality Control Analyst III in Camarillo, CA within the biotechnology and pharmaceutical industry. This role is ideal for an experienced QC professional with a strong background in analytical testing, cGMP or GLP environments, data evaluation, investigations, and stability program support.
The Quality Control Analyst III will play a key role in ensuring product quality, regulatory compliance, and reliable laboratory operations. This position offers the opportunity to work in a collaborative, quality-focused environment with cross-functional visibility, supportive leadership, and opportunities to contribute to process improvements, method validations, investigations, and departmental projects.
This is a strong fit for a detail-oriented laboratory professional who enjoys complex analytical work, problem solving, mentoring others, and helping drive continuous improvement in a regulated pharmaceutical setting.
Key Responsibilities
- Perform complex analytical testing and data evaluation using methods such as HPLC, ELISA, and other QC laboratory techniques.
- Troubleshoot laboratory equipment issues, support equipment upkeep, and communicate resolutions to management.
- Support method validations, SOP revisions, protocols, reports, investigations, change controls, and data summaries.
- Investigate OOS events, perform root cause analysis, assess product impact, and support CAPA implementation.
- Coordinate testing with outside laboratories and cross-functional departments, including raw material testing and scheduling priorities.
- Lead stability program activities, including test point management, data reporting, trend evaluation, and investigation of aberrant or out-of-specification results.
Compensation and Benefits
- Salary range: $116,188 to $175,000 per year.
- Job type: Direct hire.
- Schedule: Flexible hours may be required, including nights and weekends as needed.
- Overtime eligible.
- Benefits: Not specified.
Equal Opportunity Employer / Disabled / Protected Veterans
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For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
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Required Qualifications and Skills
- Perform complex QC testing and analytical data evaluation in a regulated pharmaceutical laboratory.
- Lead or support investigations, CAPAs, OOS evaluations, and stability program activities.
- Author, revise, and review SOPs, test methods, reports, protocols, investigations, change controls, and data summaries.
- Collaborate with internal departments and external testing laboratories to coordinate testing, priorities, and project timelines.
- Bachelor’s degree in Chemistry or a related field with 5+ years of related work experience, or Master’s degree in Chemistry or a related field with 3+ years of related work experience, or PhD in Chemistry or a related field with 1+ year of related work experience.
- Experience working in a cGMP or GLP pharmaceutical industry environment.
- Hands-on experience with analytical laboratory testing methods such as HPLC, ELISA, and related QC techniques.
- Strong understanding of pharmaceutical regulatory and compliance guidelines.
- Experience with OOS investigations, root cause analysis, CAPA support, risk assessments, and data trending.
- Ability to maintain detailed, accurate, and compliant laboratory records.
- Strong written communication skills for preparing technical documents, SOPs, reports, protocols, and summaries.
- Ability to train others, support cross-functional teams, and lead departmental or continuous improvement projects.
- Willingness to work flexible hours, including nights and weekends as needed.
Preferred Qualifications
- Experience leading or supporting pharmaceutical stability programs.
- Experience coordinating external laboratory testing.
- Experience with data management systems, tracking, trending, and presenting data summaries to management.
- Strong project leadership skills in a QC, pharmaceutical, biotechnology, or regulated laboratory environment.