Quality Control Analyst II

Vericel® Corporation; Cambridge (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Vericel Corporation is looking for a Quality Control Analyst II to ensure quality assurance of products through routine testing and validation procedures. This role requires performing various assays in compliance with SOPs and cGMP guidelines while collaborating with different teams to enhance lab operations. Ideal candidates have relevant degrees and extensive lab experience, specifically in microbiological techniques and data management.

Benefits

Opportunities for career growth

Collaborative work culture

Engagement with cutting-edge science

Qualifications

• 6+ years in cGMP lab environment or equivalent experience required.
• Degree in relevant field preferred.
• Minimum 1+ years in cell culture and microbial assays preferred.

Responsibilities

• Perform routine QC testing and environmental monitoring.
• Assist in review of QC data and manage out-of-specification results.
• Train less experienced staff and participate in method transfers.

Skills

Cell culture

Microbial assays

Molecular biology

Data management

Education

Degree in microbiology, molecular biology, biochemistry or related discipline

HS Diploma with 6+ years’ industry experience

Tools

LIMs

PCR methodology

Job description

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Talent Acquisition Supervisor at Vericel Corporation | MS, PHR

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

Responsible for performing routine and non-routine assays of raw materials, in-process samples, drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for product release and validation.

Schedule: This position is in office Tuesday - Saturday in our Cambridge, MA location.

Position Scope:

• 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.
• 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 training of less experienced staff.
• Participate in transfer methods from support groups to the QC laboratory.
• 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.
• Perform deviation and lab investigations as needed.
• Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
• Other duties as assigned.

Qualifications:

• HS Diploma, 6+ years’ industry experience in cGMP lab environment, or equivalent.
• Degree in microbiology, molecular biology, biochemistry or a related discipline. AS plus 4-5 years’ industry experience or BS plus 2+ years’ industry experience.

Preferred Qualifications:

• Minimum of 1+ years in cell culture, microbial and/or molecular assays.
• Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs).
• Experience with microbiological testing, biological assays, or environmental monitoring.
• Experience in a biotech, pharmaceutical or other regulated industry.
• Experience with PCR based methodology or cell culture methods.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

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