Quality Control Associate II

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.

Who you are

* You possess a Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline with 5-6 years of experience in pharmaceutical/biotech QC labs, including hands-on raw material testing under cGMP.

* You have proven experience with analytical instrumentation and techniques, including method development, validation, and troubleshooting.

Knowledge, Skills, and Abilities

* Advanced Analytical Proficiency:
Proven expertise in Liquid HPLC and/or Gas Chromatography, including system configuration, operation, and basic equipment troubleshooting techniques. Must have experience in general chemical testing assays.

* GMP Compliance & Quality Systems:
Extensive experience working in a GMP environment with a strong understanding of laboratory safety procedures.

* Audit & Regulatory Interaction:
Demonstrated experience in audits and inspections, including the ability to interact with and speak to auditors.

* Process Improvement & Teamwork:
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.

* Communication & Leadership:
Excellent interpersonal, written, and verbal communication skills. Includes the ability to read and interpret technical data and demonstrated leadership ability in a group setting.

* Data & Computer Systems Proficiency:
Proficiency in laboratory electronic systems, including LIMS and Microsoft Office Suite and/or Google Workspace. Must have working knowledge of Empower and/or GSMP software.

* Execution, Agility, & Organization:
Must be agile and able to work independently in a fast-paced environment with high volume testing schedules. Demonstrates excellent organizational skills and proficiency in time management.

Physical &

Work Environment Requirements

* 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).

* Work is performed in a cGMP-regulated manufacturing facility.

Travel may be up to 25% during start-up laboratory activities. No more than 10% travel expected during routine operations.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $66,200 - $110,000 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company…