The QC Laboratory Specialist supports the manufacture and release of products and incoming materials by performing routine quality control activities. This role requires a strong understanding of scientific principles, analytical methods, and GMP compliance to ensure data integrity and product quality.
Key Responsibilities:
Lead and execute testing following written methodologies, ensuring results are reported clearly and accurately, maintaining data integrity from the first attempt. Demonstrate a deep understanding of the scientific principles and method validation for the assays conducted.
Oversee and manage the utilization of chromatography technologies to conduct complex assays, ensuring proper calibration and maintenance of chromatography equipment for the highest accuracy in results.
Critically review and evaluate GMP assay data, providing comprehensive insights and effectively communicating findings to manufacturing teams for alignment and adherence to quality standards.
Execute and prioritize tasks with minimal supervision, demonstrating exceptional decision-making skills in complex situations and leading lab investigations to resolve issues.
Coordinate and schedule preventative maintenance activities with external vendors, ensuring all laboratory equipment is maintained in optimal condition and readiness.
Revise and enhance standard operating procedures as needed, supporting Process Owners and providing expertise to maintain and improve applicable methods.
Design and implement comprehensive training programs for team members on applicable procedures, ensuring consistency, compliance, and high performance within the team.
Serve as a subject matter expert on multiple methods/topics within the team, providing advanced knowledge and insights to drive innovation and excellence, and mentoring team members to foster professional growth.
Ensure compliance with current GMP regulations and quality systems, promoting a quality mindset throughout the department, and proactively identifying, escalating, and preventing safety issues.
Always maintain the area of responsibility in a state of inspection readiness, demonstrating proactive compliance with all regulatory requirements and performing other departmental duties as assigned by management.
Previous leadership experience
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
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1. Gas Chromatography (GC) Instrument Performance Qualification (PQs)
Perform PQs for three different GC methods to ensure instrument reliability and compliance.
o Develop PQ protocols for each GC method.
o Execute PQ testing and document results.
o Compile and finalize instrument PQ reports.
2. Gas Chromatography Installation, Operational, and Qualification (IOQ) for New GC Laboratory
Collaborate with laboratory staff to plan the installation of new GC instruments.
Execute internal IOQ protocols for new laboratory GC instruments.
Document and finalize IOQ reports for compliance.
3. Method Validation Work
QS-21 Methods (Enzymatic Conversion Project)
Develop and optimize enzymatic conversion methods for QS-21 analysis (as applicable).
Execute method validations according to regulatory guidelines (e.g., ICH Q2).
Prepare validation reports and supporting documentation.
MPL Congeners Method (UPLC-MS)
Optimize UPLC-MS methods for MPL congeners analysis.
Work with team to draft method validation protocol, perform method validation testing, and write report.
Compile validation documentation for regulatory requirements.
4. Empower Software Upgrade to Version 3.9
User Acceptance Testing (UAT) Qualifications
Coordinate with OneCDS for the design of UAT protocols to test Empower version 3.9 functionality.
Execute UAT testing with real-world scenarios and document findings.
Resolve system issues identified during UAT and retest as required.
5. Enzymatic Conversion Project PPQ testing
Provide support by executing PPQ testing
6. Additional Tasks
Ensure seamless transition of existing methods and data to Empower 3.9.
Train laboratory personnel on Empower 3.9 features and workflows.
Provide technical support during and after the upgrade process.
Invalid rate reduction initiative
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.