Senior QC Analyst
Bothell, WA
Experience: 0
Category: Scientific & Clinical
Brand: Joulé
Compensation Range: 55.00 - 60.00 Per Hour
Job ID: 317912
Date Posted: 04/03/2024
Shortcut: http://jobs.systemone.com/8nbQYv
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, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions 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 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.
-
Technical Writer
Bothell, WA
Job Title: Technical Writer Location: Bothell, WA Compensation: $52.00 - $62.29/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbio...
Date Posted: 03/22/2024 Recommended
-
Deviation Investigator
Bothell, WA
Job Title: Deviation Investigator Location: Bothell, WA Compensation: $53.00- $63.86 Type: Contract Overview Leading biopharmaceutical company looking for an experience Deviation Investigator. Ideal candidates should have 5+ years of relevant GMP exper...
Date Posted: 04/02/2024 Recommended
-
QC Auditor I
Iron Station, North Carolina
Title: QC Auditor I Location: Iron Station, NC area Duration: Contract to hire Schedule: M-F Full Time Start Date: ASAP Responsibilities: The purpose of this position is to review QA/QC documentation, to assess data compliance/validity with regulatory ...
Date Posted: 04/11/2024 Recommended
-
Sr. Research Associate - Analytical Testing
Cambridge, MA
Title: Sr. Research Associate - Analytical Testing Location: Cambridge, MA. area Start Date: ASAP! Duration: Minimum 12 month contract (possible contract-to-hire) Hours: Mon-Fri; 8am-4pm (could be flexible to 7am-3pm or 9am-5pm) Degree/Experience/"Must...
Date Posted: 04/10/2024 Recommended
-
Quality Control/R&D Scientist
Exton, PA
Title: Quality Control/R&D Scientist Location: Exton, Pa Schedule: M-F 8am-4:30pm with the possibility of occasional weekends or off-shifts Type: 6 month Contract to Hire Start date: Immediate Our client is a late-stage cell and gene therapy company se...
Date Posted: 04/12/2024 Recommended
-
Senior Quality Control R&D Scientist
Exton, PA
Title: Sr. Quality Control R&D Scientist Location: Exton, Pa Schedule: M-F 8am-4:30pm Type: 6 month contract to hire based on performance Start date: Immediate Our client is a late-stage cell and gene therapy company seeking a senior-level candidate wh...
Date Posted: 04/12/2024 Recommended
-
Quality Control Laboratory Manager
Exton, PA
Title: Quality Control Laboratory Manager Location: Exton, PA Type: Contract to hire Schedule: Monday – Friday 8AM-5PM Overview: Growing Biopharmaceutical Company is looking for a hands on manager to lead and oversee their QC Lab in operational activit...
Date Posted: 04/24/2024 Recommended
-
Research Scientist
Seattle, WA
Job Title: Research Scientist Location: Seattle, WA Compensation: $51.00 - 61.00/hr Type: Contract, Potential for extension or conversion to permanent Responsibilities The Scientist will independently develop and execute plate-based assays in support o...
Date Posted: 03/26/2024 Recommended
-
Manufacturing Associate II - Downstream
Rockville, Maryland
Title: Manufacturing Associate II/III Location: Rockville, MD Type: 12+ Month Contract potential for extension or hire Start Date: Immediate Overview: The Manufacturing Associate II/III participates in the cell culture manufacturing of biopharmaceutica...
Date Posted: 04/08/2024 Recommended
-
Research Scientist
Ames, IA
Job Title: Research Scientist Location: Ames, IA Hours/Schedule: M-F, 8AM - 5PM Type: Contract, Potential for extension or conversion to permanent Responsibilities Experience in performing bio-analytical methods (immunological, microbiological, molecul...
Date Posted: 04/15/2024 Recommended
-
QA Technician
Swedesboro, New Jersey
QA Technician Perm Pay rate: $21 - $23/hour 8 a.m. - 4:30 p.m. ESSENTIAL DUTIES & RESPONSIBILITIES • Ensure compliance with HACCP and GMPs for all operational activities • Conduct sampling and analytical testing of products • Monitor and maintain raw m...
Date Posted: 04/22/2024 Recommended
-
Manufacturing Technician
Rockville, MD
Job Title: Manufacturing Technician - Biopharmaceutical Location: Rockville MD Schedule: Mon-Fri 8am-5pm Type: 12 month contract Start: Immediate Overview: Growing Biopharmaceutical Company is looking for Manufacturing Technicians to join their team on...
Date Posted: 04/12/2024 Recommended
-
QC Technician III
Saint Joseph, MO
Job Title: QC Technician III Location: St. Joseph, MO Type: Contract Responsibilities Perform microbiological methods including microbial identification and environmental monitoring of classified environments. Responsible for timely communication with ...
Date Posted: 04/26/2024 Recommended
-
Metrology Specialist
New Brunswick, NJ
Job Title: Metrology Specialist Location: New Brunswick, NJ Type: Contract Overview A Leading pharmaceutical company, with a location in NJ is looking to bring on a Metrology Specialist to join their team. Candidates with equipment calibration/ mainten...
Date Posted: 04/10/2024 Recommended
-
Protein Biologics QC Analyst 2
Exton, PA
Job Title: Protein QC Analyst 2 Location: Exton, PA Type: Contract Overview Join a pharmaceutical company operating globally in terms of R&D, manufacturing and marketing, with a strong focus on prescription medicines. Looking for 2-4 yrs of cGMP experi...
Date Posted: 04/23/2024 Recommended