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

Role Summary

The QC Scientist, Raw Materials will support the QC Raw Materials program by inspecting and sampling incoming GMP raw materials and manufacturing supplies, performing related equipment cleaning and maintenance, and providing documentation support. This role collaborates with Manufacturing, Materials Management, Quality Assurance, Procurement, QC staff, and outsourced testing laboratories to meet business goals and regulatory compliance. Candidates should have GDP experience, be detail-oriented, self-motivated, and able to work independently; experience with fume hoods, laminar flow hoods, balances, aseptic technique, and cleanroom gowning is highly desirable. Location: Redmond, WA. Shifts: Days, Monday to Friday.

Responsibilities

• Execute the daily activities (in warehouse, laboratory, and cleanroom environments) of the QC Raw Material group in support of inspection, sampling, and testing as per written specifications and compendial methods
• Inspect material containers, labels, and associated documentation for integrity and compliance with written specifications
• Initiate investigations for container integrity or compliance issues found during the inspection/sampling process
• Manage inventory of raw material samples
• Coordinate attribute testing (internal or external) for batch release
• Maintain lab spaces and supply stocks
• Provide subject matter expertise during internal project team meetings
• Support investigation and closure of deviations, CAPAs, etc.
• Collaborate with Quality Assurance, Manufacturing, Materials Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved
• Use various software tools to support tracking of material release status (Excel, SAP, LIMS, etc.)
• Safely use laboratory equipment and instruments (e.g., FTIR, pH meter, osmometer, etc.)
• Maintain a clean and organized work area to ensure material segregation and prevent cross contamination
• Write, revise, or review SOPSs and job aids
• Perform primary review of laboratory data and documentation
• Train and mentor junior colleagues
• Be proficient in aseptic sampling techniques and ensure all cGMP documentation is ALCOA

Qualifications

• BS Chemistry or related science with 3+ years related experience
• Experience in a quality control or production environment in a cGMP facility
• Experience in a raw materials testing or chemistry laboratory
• Experience with aseptic technique
• Ability to understand and follow compendial (USP, EP) testing instructions and in-house procedures
• Strong adherence to data integrity requirements
• Knowledge of current instrumentation and procedures used in an analytical laboratory
• Knowledge of Material Safety Data Sheets and safety precautions
• Legible penmanship
• Ability to perform multiple tasks simultaneously, manage time effectively, and adapt to changing priorities
• Ability to succeed with minimal supervision
• Excellent oral and written communication skills
• Must demonstrate initiative, resourcefulness, and flexibility to work independently and as part of a team
• Ability to interact constructively with co-workers
• Demonstrated meticulous attention to detail and sense of craftsmanship

Additional Requirements

• Lift up to 60 pounds and perform related movements (kneeling, crouching, twisting, walking, bending, stooping, pushing, pulling, and reaching)
• Routinely wear applicable personal protective equipment (PPE)
• Work with various laboratory cleaning agents and chemicals
• Train on and wear a respirator, as applicable
• Tolerance of cold-room (2-8°C) conditions
• Tolerance of medium noise levels