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

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.