Quality Control Analyst, I

Vericel Corporation•Burlington, MA

17h•Onsite

About The Position

The Quality Control Analyst I is responsible for performing routine testing of raw materials, in-process, drug product (DP) and stability samples within the QC laboratory in accordance with SOPs for product release and validation.

Requirements

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

Nice To Haves

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.

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.