QC Raw Materials Manager

This position oversees and participates in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. This role works collaboratively with other teams to ensure that raw materials are released in a compliant manner prior to their need-by dates. The role requires extensive cGMP compliance experience, exceptional attention to detail, and experience designing and implementing efficiency improvements.

Responsibilities

• Lead a QC raw materials testing program to support commercial manufacturing.
• Oversee the inspection, sampling, and testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP requirements.
• Ensure materials are sampled in accordance with SOPs, entered into the data management systems, and are available for use on time.
• Participate in the qualification of raw materials via external and in-house testing.
• 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, Materials Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
• 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.
• Support onboarding and qualification of analytical equipment.

Requirements

• BS in Chemistry, or related field with a minimum of 5+ years of relevant experience within the pharmaceutical industry and a minimum of 3+ years of hands-on, industry experience managing in a cGMP QC laboratory.
• Extensive experience with raw material sampling, including handling of powders and liquids, using aseptic techniques.
• Knowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, FTIR, HPLC, etc.
• Knowledge of verification and validation of assays required for raw material testing.
• 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.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.