System One • Bothell, WA 98021
Job #2674837378
Title: Senior QC Analyst
Location: Bothell, WA
Start date: ASAP
Pay Rate Range: $55 - 60/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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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