Analyst I, QC Raw Materials

Job Overview

The Quality Control (QC) Raw Materials Analyst ensures the quality of raw materials for the Manufacturing Department in compliance with cGMP, USP, EP, and JP guidelines as well as company policies and procedures. This role supports day-to-day operations including sampling, internal and external testing, raw material release, and QMS activities (Deviations, CAPA, Lab Investigations (OOS, AR, OOT), Documentation (SOPs / Forms / Material Specification), laboratory operations, and Training). It also supports method validation / verification for onboarding new raw materials and participates in internal / external audits.

Responsibilities

• Support routine and non-routine internal / external FIFO testing of raw materials, including sampling, inspection, internal testing, and review (FTIR, pH, wet chemistry, dimensional analysis, visual inspection) in accordance with procedures / USP / EP / JP / ACS Reagent Index
• Support shipment of raw materials to CTL for Raw Material Qualification and Process / Product testing
• Maintain QC raw material related systems to ensure compliance with industry standards and regulatory requirements
• Support Deviations, Lab Investigations (OOS, AR, OOT), and CAPA
• Write and revise SOPs, including periodic review of GMP documents
• Provide training to other analysts within the department as appropriate
• Generate, maintain, and archive Equipment / System / Process logbooks
• Initiate and track Work Orders in BRAM
• Support internal and external audits as required
• Contribute to continuous improvement of the raw materials testing / sampling program, including material specifications for increased efficiency
• Adhere to GDP / ALCOA+ principles and communicate any procedural ambiguities or deviations with proposed solutions
• Troubleshoot instrument / method / operational system errors with guidance
• Recognize when escalation to supervisor is needed to complete workload

Qualifications

Physical Demands

Requires work in a BSL-2 environment with PPE / aseptic gowning; work around large machinery and typical pharmaceutical facility utilities; potential exposure to moving parts, high places, hazardous chemicals, and loud noise; and the ability to lift up to 25–50 pounds as needed. May require standing, walking, bending, stooping, and other physical activities.

Genezen's Values

G enezen is committed to science, innovation, and data-driven decisions to advance healthcare.

U rgency in action for patients; delivering timely treatments by accelerating programs.

R esilience and grit in operations; overcoming challenges and learning from failures.

E xecute with excellence and integrity; delivering quality results and ethical practice.

S olutions driven for partners; proactive, collaborative, and open-minded.

Equal Opportunity Employer

Genezen is an Equal Opportunity Employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. We participate in EVerify where applicable.

#J-18808-Ljbffr