QC Manager, Raw Materials - Site , Redmond, WA

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.

• 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.

Base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; this is a salary exempt role. Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short‑term and long‑term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation or veteran status.