Quality Control Analyst, II

Vericel® Corporation; Burlington (MA); On-site; USD 46,356 - 52,982; Full time

Benefits offered by this job

Career Growth Opportunities

Collaborative Work Environment

Job summary

A leading biotech company is seeking a Quality Control Analyst for their laboratory in Burlington, MA. This role involves performing routine and non-routine assays of raw materials and drug products while adhering to cGMP guidelines. Candidates should have a relevant degree and several years of laboratory experience, specifically in microbiology and QC testing. The position is onsite 5 days a week, with a collaborative culture and opportunities for career growth.

Qualifications

• Experience in a cGMP lab environment.
• Ability to perform quality control testing and analyze results.
• Familiar with environmental monitoring processes.

Responsibilities

• Perform routine QC testing for raw materials and products.
• Conduct microbial and molecular assays.
• Report any deviations in results to management.

Skills

Cell culture assays

Microbial assays

Molecular biology

cGMP compliance

Technical problem solving

Education

High School Diploma with 6+ years experience

Degree in Microbiology or related field with required experience

Tools

Balances

Pipettes

pH meter

UV/Visible spectrophotometer

Plate reader

Laboratory data management systems

Job description

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 onsite 5 days a week in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility. The two available shifts are Tuesday - Saturday and Sunday - Thursday.

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.
• 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.
• 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. BS plus 3+ years’ industry experience. MS plus 0-1 years’ industry experience in cGMP lab environment, or equivalent.

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.
• Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.

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.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $33.65 to $38.46 hourly.

The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

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.