Title : Senior QC Analyst
Location : Bothell, WA
Start date : ASAP
Pay Rate Range : $60 - 70/hr
Performs routine and non-routine testing with expert proficiency and general QC laboratory work for release of Direct Raw Materials to support clinical development and/or commercial products in a GMP testing environment.
Principal Responsibilities
• Applying the principles of good manufacturing practices (GMP) on a daily basis
• Performing sample testing for raw material release testing
• Analyzing and compiling data and preparation of reports
• Reviewing assays/data for compliance to specifications and reports abnormalities
• May require lifting/moving heavy objects
• Supporting/managing the daily activities of the lab (responding to RUSH requests, starting raw material batches, assigning of assays)
• Support Release of raw material lots, CoA generation and approval
• Creating and revising standard operating procedures (SOPs, Specifications, and Test Methods) and other documents as needed
• Identifying and leading continuous improvement projects
• Supporting special projects for analytical problem solving
• Participating in the qualification and validation of test methods
• Troubleshooting laboratory or system anomalies
• Authoring and owning deviations, CAPAs and Change Controls
• Method or system development and/or optimization.
• Training other personnel
• Serving as SME for Test Methods or other areas of expertise
• Providing oversight for programs, specific to job function
• Representing QC in cross-functional teams
• Weekend, Holiday, overtime, and off-hour work may be required as needed to support manufacturing.
Expected Qualifications
• Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience)
• Broad experience with Microsoft Office products
• Be highly organized with an attention to detail
• Strong data interpretation/analytical skills
• Strong troubleshooting skills
• Strong knowledge of GMP compliance
• Strong technical writing and communication skills
• Experienced in lab equipment (pH meters, balances, pipettes, HPLC's/plate readers, automated titrators, spectrophotometric instrumentation, etc.)
• Experience authoring or revising Standard Operating Procedures
• Familiarity with Change Control
• Participation in Laboratory Investigations
• Ability to keep order of multiple projects/tasks
Preferred Qualifications
• 4+ years of experience working in a GMP laboratory
• Participation in Laboratory or Out of Specification Investigations
• Experience or working knowledge of compendial methods/monographs as it applies to raw material testing
