Senior Associate, QCA - Raw Materials

ImmPACT-Bio is seeking a QC Sr. Associate in the Quality Control organization to support the development, implementation, and maintenance of the raw material program for Clinical and future Commercial Manufacturing of the new GMP cell therapy production facility located in West Hills, CA. This individual will work closely with cross-functional teams (e.g., Manufacturing, Quality Assurance, Supply Chain, etc.), as well as internal and external laboratories for conducting comprehensive testing and analysis of raw materials used in the production of biotechnological products.

The ideal candidate must be knowledgeable of raw material processes, cGMP, regulations, quality lab investigation and will have a strong background in biology, biochemistry, or a related scientific field, with experience in laboratory procedures and techniques. In this role, the candidate will be expected to have subject matter oversight, expertise on raw material and incoming testing material processes, and experience with international compendial test method performance. This individual will perform all activities in a cGMP environment following relevant SOPs, make and maintain accurate documentation, monitor details and report any deviation to management as needed. This full-time position reports to the Manager of Quality Control Analytical.

Primary Responsibilities: 

• Lead and maintain raw material program in compliance with regulatory requirements and commitments for clinical and future commercial products.
• Support testing of raw materials according to established procedures and protocols.
• Manage qualified internal and contract laboratories for testing of raw materials.
• Maintain inspection process, develop sampling strategies, and AQL for incoming GMP materials.
• Identify and investigate deviations or discrepancies in raw material quality and collaborate with cross-functional teams to address issues and implement corrective actions as necessary.
• Draft, review, and approve raw material related documentation in accordance with GMP standards and company policies.
• Maintain, review, and document internal/external test results, and collaborate with internal departments on timely raw material disposition.
• Report out-of-specification results and support investigations, CAPAs, and internal/external audits, implement corrective and preventative actions as necessary.
• Monitor and trend data, complete routine record review of test data and related documents for raw materials.
• Collaborate closely with cross-functional teams to coordinate the timely receipt, testing, and release of raw materials for manufacturing operations.
• Perform routine operations in accordance with cGMP requirements, including but not limited to instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, raw material sampling and testing, record keeping, etc.
• Maintain strong interactions with peers, department management, and internal departments and support a positive employee relations climate.
• Contribute to continuous improvement initiatives, enhance efficiency, streamline workflows, stay current on emerging technologies, and regulatory changes.
• Ability to work shift-style work schedule with weekend support.
• Perform other duties, as assigned.

Qualifications: 

• Bachelor's degree in biology, chemistry, biochemistry, or a related scientific field with 2+ years of experience in a cGMP compliant environment or equivalent combination of education and experience. 
• Knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to raw materials.
• Proficiency in facilitating and conducting risk assessments with a strong understanding of risk assessment principles.
• Experience managing suppliers and/or contract testing laboratories.
• Familiarity with regulatory requirements (e.g., FDA, cGMP) governing raw material testing in the biotech industry.
• Ability to prioritize tasks, manage time efficiently, and adapt to changing priorities in a fast-paced work environment.
• Commitment to safety, quality, and continuous improvement in all aspects of laboratory operations.
• Experience in maintenance of GMP laboratory equipment and supplies.
• Proficiency in a range of analytical techniques and instrumentation, with hands-on experience in methods such as HPLC, GC-MS, FTIR, and UV-Vis spectroscopy is a plus.
• Demonstrated knowledge and experience in “core” laboratory techniques (ELISA, Cell culture and Cell-based assay, PCR, Flow cytometry, etc.) is a plus.
• Experience in supporting OOS investigation and CAPA initiation is a plus.
• Able to follow instructions and SOPs precisely and able to make/keep accurate documentation.
• Able to learn new skills rapidly and achieve proficiency.
• Detail-oriented with good written and verbal communication skills.
• Good organizational and planning skills, and an ability to work efficiently.
• Able to seek and accept input from more senior team members for the performance of assignments as needed.
• Strong attention to detail and accuracy in record-keeping and data analysis.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
• Team player with good interpersonal skills.

Location:  

• West Hills, California  

Travel Requirements:  

• Up to 15% travel. 
• Willingness to travel domestically and internationally for business meetings and scientific conferences.