QC Manager, Raw Materials - Site Based, Redmond, WA

QC Manager, Raw Materials - Site Based job at Just Evotec Biologics in Redmond, WA. The role involves leading a QC raw materials testing program, overseeing the inspection and testing of incoming raw materials, and collaborating with Quality Assurance, Manufacturing, and external vendors. The ideal candidate has a BS in Chemistry or a related field, 5+ years of relevant experience, and excellent communication and collaboration skills.

Requirements

• BS in Chemistry, or related field
• 5+ years of relevant experience within the pharmaceutical industry
• 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

• Medical, Dental and Vision
• Short-term and long-term disability
• Company paid basic life insurance
• 401k company match
• Generous paid time off
• Paid holiday
• Wellness and transportation benefits