Quality Control Associate II
About The Position
We are seeking an experienced QC Associate II to support direct material (raw material) testing. This role requires technical proficiency in chemical assays and compendial testing, balancing hands-on routine and non-routine analysis with significant responsibility in technical expertise, troubleshooting, and training. The successful candidate will maintain the lab in an audit-ready and compliant manner, apply strong analytical and interpretive skills to investigate anomalous data OOS/OOT, drive process improvements, and contribute to regulatory documentation and Technical Transfer activities to ensure the long-term technical competence and efficiency of the laboratory. The Opportunity Serves as the site SME for complex technical troubleshooting of established methods and instrumentation. Initiates and drives OOS/OOT laboratory investigations. Acts as a technical liaison for method performance issues and continuous improvement projects. Method Transfer Collaboration: Works in close collaboration with the external sites and Validation teams to execute and verify Analytical Method Transfer Protocols. Technically capable for testing of compendial and non-compendial methods such as but not limited to: FTIR, NIR, HPLC, UV/Vis, GC, wet chemistry, MS, Karl Fischer, and titration. Collect, process and report on data for samples associated with direct material (raw material) and in-process testing from the clinical and/or commercial manufacturing facilities Primary Training & Documentation: Translates knowledge transfer into SOPs a. Serves as the primary instructor for junior analysts, managing proficiency testing, and overseeing on-the-job training. Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information. Responsible for collecting, entering data and generating reports from electronic systems. All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA). Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
- 5-6 years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.
- Proven experience with analytical instrumentation and techniques, including method development, validation, and troubleshooting.
- Proven expertise in Liquid HPLC and/or Gas Chromatography, including system configuration, operation, and basic equipment troubleshooting techniques.
- Experience in general chemical testing assays.
- Extensive experience working in a GMP environment with a strong understanding of laboratory safety procedures.
- Demonstrated experience in audits and inspections, including the ability to interact with and speak to auditors.
- Possesses a continuous improvement mindset and actively seeks ways to improve procedures or assays.
- Experience working effectively on group projects and actively engaging in team meetings.
- Excellent interpersonal, written, and verbal communication skills.
- Ability to read and interpret technical data.
- Demonstrated leadership ability in a group setting.
- Proficiency in laboratory electronic systems, including LIMS and Microsoft Office Suite and/or Google Workspace.
- Working knowledge of Empower and/or GSMP software.
- Must be agile and able to work independently in a fast-paced environment with high volume testing schedules.
- Excellent organizational skills and proficiency in time management.
- Must be able to stand, walk, and use laboratory equipment for extended periods.
- Ability to lift up to 35 lbs and wear necessary personal protective equipment (PPE).
Responsibilities
- Serves as the site SME for complex technical troubleshooting of established methods and instrumentation.
- Initiates and drives OOS/OOT laboratory investigations.
- Acts as a technical liaison for method performance issues and continuous improvement projects.
- Works in close collaboration with the external sites and Validation teams to execute and verify Analytical Method Transfer Protocols.
- Testing of compendial and non-compendial methods such as but not limited to: FTIR, NIR, HPLC, UV/Vis, GC, wet chemistry, MS, Karl Fischer, and titration.
- Collect, process and report on data for samples associated with direct material (raw material) and in-process testing from the clinical and/or commercial manufacturing facilities.
- Translates knowledge transfer into SOPs.
- Serves as the primary instructor for junior analysts, managing proficiency testing, and overseeing on-the-job training.
- Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information.
- Responsible for collecting, entering data and generating reports from electronic systems.
- Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.
- Fosters a positive safety culture in which no one gets hurt.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
