FierceBiotech and FiercePharma Jobs
Quality Control Analyst I (Biology) - Celsis
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Website: http://www.celsis.com
Position Description
At Celsis our people are our competitive advantage. Our employees come from diverse backgrounds and have wide-ranging skills, but we all share the same mission and core values. Celsis is committed to recruit, retain and promote individuals with compassion, character, confidence, and commitment. Looking beyond the present and challenging the notion about what is possible is what we do and what we expect from our team.
Our employees, in all of our locations, thrive in an exciting, high-energy atmosphere and believe in the power of the team being greater than the sum of its parts. At Celsis, we offer a comprehensive employee benefits portfolio including flexible healthcare options, performance-based incentives, a great time-off program, retirement savings plans and more.
If you’re looking for a great new career with one of the leading contract laboratories and ready to discover what it’s like to be a part of a truly exceptional organization, we invite you to view our current openings.
Purpose of Position
The Quality Control Analyst is responsible for performing assays and reviewing data from the analysis of samples to support Product Operations and for verifying that products meet specification for release and/or stability.
Responsibilities and Duties
Perform biological quality control and/or stability analysis of samples obtained from Product Operations as specified by approved SOPs and/or Methods.
Write/Revise SOPs and/or Test Methods as applicable.
Ensure all laboratory documents are completed within specified timelines.
Maintain accurate and concise documentation of testing conducted and resulting data. Review data obtained for compliance to specifications and report abnormalities.
Work with manager to conduct laboratory investigations related to product testing.
Prepare release documentation (Product Data Sheets/Certificates of Analysis).
Maintain supply levels for performance of assigned duties.
Maintain instrumentation and other laboratory equipment according to maintenance schedules and departmental procedures.
Prepare release documentation (Product Data Sheets/Certificates of Analysis).
Train other analysts in biological (cell culture/plate-based) Quality Control procedures as required.
Accurately maintain appropriate quality control files and databases.
Perform appropriate tracking/trending of data for potential process improvement or QC metric monitoring as specified by QS management.
Apply good laboratory practices as appropriate and participate in problem solving as required.
Maintain orderly, clean and safe workplace
Qualifications/Skills and Knowledge Requirements
Bachelor degree in Biology or a related scientific field with 2-5 years relevant experience (or M.S. degree in a scientific field with 1-2 years relevant experience) or equivalent combination of education and experience with laboratory procedures, including but not limited to: serial dilutions, aseptic transfers, cell incubation/counting, plate reading and microscopy.
Familiarity with GLP and GMP.
Cell culture or microbiology laboratory experience a plus.
Accurate pipetting skills essential.
Must be organized, show attention to detail and demonstrate good documentation practices.
Must have mathematical aptitude for performing data calculations.
Basic knowledge and experience with Microsoft Excel, Access and Word programs.
How to Apply
For IMMEDIATE consideration, please e-mail a copy of your resume with salary requirements and a daytime phone number to crussell@celsis.comApplication Instructions / Send a Resume
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