QC Supervisor/Manager, Raw Materials

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. The candidate will provide leadership in a fast paced, collaborative QC group. The candidate will oversee and participate in the sampling and external testing of incoming raw materials prior to their use in cGMP manufacturing. The candidate will work collaboratively with other teams to ensure that raw materials are released prior to their need by dates in compliant manner. The successful candidate will have extensive cGMP compliance experience, exceptional attention to detail and have experience designing and implementing efficiency improvements.

Responsibilities:

• Lead a QC raw materials testing program to support commercial manufacturing
• Oversee the inspection, sampling, and external testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP requirements
• Ensure materials are sampled in accordance to SOPs, entered into the data management systems, and are available for use on time
• Participate in the qualification of raw materials via external testing
• Lead the implementation of a Raman based ID testing program
• Serve as subject matter expert in review of raw material specifications
• Participate in vendor audits as a technical advisor
• Oversee the daily routine activities of the raw materials group, provide data review and ensure the operation remains compliant at all times
• Collaborate with Quality Assurance, Manufacturing, Material Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
• Provide expertise for the IOPQ of Raman instrumentation for raw material ID testing, including troubleshooting and routine equipment maintenance
• Author and maintain required cGMP documentation such as SOPs and guidance documents
• Oversee verification of assays at external testing labs
• Identify gaps, design collaborative solutions, and implement improvements
• Participate in external testing labs QC laboratory investigations, deviations, OOS, and CAPAs

Requirements:

• BS in Biochemistry, Chemistry, or related field with >5-8 years cGMP experience with raw materials
• Extensive experience with raw material sampling, including handling of powder and liquids, using aseptic techniques
• Knowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, HPLC, etc.
• Knowledge of verification and validation of assays required for raw material testing
• Experience with Raman for ID
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA)
• Extensive knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP)
• Excellent communication and collaboration skills
• Attention to detail, highly organized, able to meet schedules and timelines and handle multiple priorities