This role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready.
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality Control Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Senior Quality Control (QC) Analyst is responsible for performing routine and non-routine assays of in-process samples, finished drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for product release and validation. This role also participates in special projects, method development/transfers and cleaning study qualifications as needed.
DUTIES AND RESPONSIBILITIES
- Perform microbiological, molecular and/or cell culture assays for in-process, final product and stability samples.
- Perform microbial limits, Bioburden testing, and identifying and trending microorganisms.
- Participate in method qualification/validation activities as necessary.
- Provide training and technical leadership to less experienced staff.
- Analyze, document, and trend QC data in accordance with Vericel requirements.
- 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.
- Author and conduct periodic review to QC documents, including SOPs, protocols and forms.
- Assist QC Management, as needed, in the completion of OOS, deviations, change controls and CAPAs.
- Utilize a range of electronic systems such as LIMS and document/equipment management software.
- Collaborate with internal departments and teams to support QC testing, change controls, and CAPAs.
- Actively promote safety rules and awareness. Reports and takes initiative to correct safety & environmental hazards. Always demonstrate good safety practices including the appropriate use of protective equipment.
- Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
- Back up for QC instrument maintenance and calibration.
- Backup for QC sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure.
- Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.
- Work on special projects as needed and contribute towards continuous improvement.
- Other activities as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- BS/MS degree in microbiology, molecular biology, biochemistry or a related discipline. BS, 5+ years’ industry experience. MS, 3+ years’ industry experience in cGMP lab environment.
- Ability to work independently with little supervision and/or function independently, exercise good judgement and work in a team-based environment.
- Demonstrate knowledge of cGMP/ICH/FDA/EU regulations, quality systems and regulatory requirements.
- Collaborative team player who fosters open communication and builds relationships with stakeholders.
- Exercise judgment and decision making when problem solving.
- Excellent written and verbal communication skills.
- Ability to manage competing priorities or projects.
- Ability to pay attention to detail as applied to data review and compliance.
- Strong organization, and communication skills with a positive attitude.
- Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
Preferred Qualifications:
- Experience with Deviation Management and Change Control.
- Experience with complex analytical methods or cell culture methods.
- Experience with assay/equipment validations/transfers.
- Excellent technical writing and investigational skills.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Ability to lift 40 lbs.
- Required to work one day per weekend.
- Rotating holiday coverage
- May carry company issued cell phone for off-shift remote alarm coverage.
- Required to gown into classified manufacturing clean room areas.
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.
