Quality Control Analyst, I jobs in United States
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Vericel® Corporation · 1 day ago

Quality Control Analyst, I

Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care. The Quality Control Analyst I is responsible for performing routine testing of raw materials and drug products within the QC laboratory to ensure compliance with SOPs and cGMP guidelines.

BiotechnologyLife ScienceTherapeutics

Responsibilities

Perform routine QC testing for raw materials, in-process, DP, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc. in accordance with SOPs and cGMP guidelines
Perform cell culture microbial and/or molecular assays
Perform routine Environmental Monitoring and utilities testing
Perform microbial limits, Bioburden testing, and identifying and trending microorganisms
Lab support including but not limited to glass washing, autoclaving, etc
Assist in the review of QC data and provide summaries to management as needed
Report out-of-specification or out-of-trend results in a timely manner to ensure appropriate actions are taken
Performance of QC general laboratory equipment calibration and maintenance, laboratory housekeeping and preparation of the laboratory for audits
Participate in transfer methods from support groups to the QC laboratory
Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
Communicate inter-departmentally and with outside contacts to solve technical issues
Exercise sound judgment and decision making when problem solving
Author and conduct periodic review to QC documents, including SOPs, protocols and forms as needed
Initiate deviations and lab investigations as needed
Practice safe work habits and adheres to Vericel’s safety procedures and guidelines
Other duties as assigned

Qualification

CGMP regulationsMicrobiological testingLaboratory data managementCell culture assaysEnvironmental monitoringOutlookMS WordExcel

Required

BS plus 0-2 years' industry experience in cGMP lab environment, or AS, 2-4 years' industry experience
HS Diploma, 4+ years' industry experience in cGMP lab environment, or equivalent
Basic working knowledge of cGMP regulations and/or lab experience

Preferred

1 year of experience in a cGMP lab environment
Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs)
Experience with microbiological testing or environmental monitoring
Experience in biotech, pharmaceutical or other regulated industry

Benefits

Bonus
Incentive pay
Equity
Benefits

Company

Vericel® Corporation

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Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets.

Funding

Current Stage
Public Company
Total Funding
$157.3M
Key Investors
Eastern Capital
2018-06-07Post Ipo Equity· $74.8M
2016-12-16Post Ipo Equity· $20M
2012-03-09Post Ipo Equity· $40M

Leadership Team

J
Jonathan Siegal
Vice President and Corporate Controller
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Karen Mahoney
Chief Human Resources Officer
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Company data provided by crunchbase