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 QA 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 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 Quality Operations Supervisor leads a team of QA Specialists. The individual is responsible for the oversight as well as participation in the day-to-day Quality Operations activities which includes the disposition of in-process materials and final product packaging and release. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
This position is also responsible for the being a quality reviewer for deviations, events and CAPAs. This includes providing metrics and adherence to timelines. The individual will be required to maintain a positive relationship and to effectively communicate with other departments to meet company goals.
DUTIES AND RESPONSIBILITIES
Staff Management:
Develop and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
Develop work plans, assign tasks, and supervise team(s).
Ensure staff has appropriate knowledge of department processes and procedures.
Reconcile and approve time detail for employees in ADP and conduct regular 1:1s.
Hold monthly staff meetings.
Department Management:
Establish and report applicable department or organizational metrics which drive accountability.
Accountable for project completions and achievement of compliance goals.
Represent department in project team meetings.
Interact with project teams and cross-functional groups.
Address and/or escalate site compliance problems and issues.
Lead and facilitate meetings/workshops.
Additional Responsibilities:
Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
Ensure operations documentation meets established requirements for cGMPs, internal SOPs, and company policies.
Conduct review of testing results in support of release of intermediates and final product.
Assist in deviation/nonconformance identification and resolution.
Participate and/or help lead root cause analysis to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution.
Initiate, lead, and act as SME for change controls.
Able to independently make decisions on intermediate issues and escalating major issues to Senior Management.
Perform validation protocol or final report review to ensure validation criteria and results are appropriate and comply with regulations and current industry standards.
Interpret complex, explicit documentation to ensure quality standards and compliance are met.
Provide training to new employees.
Review and approve deviations, in support of product release.
Ensure completion of organizational projects and goals.
Represent organization on specific projects.
Participate in the internal audit program, as necessary.
Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Bachelor's degree or equivalent in related field or the equivalent combination of education and/or experience.
5+ years or more of increasingly complex quality assurance or manufacturing experience in the Biotech / Pharmaceutical industry.
Strong interpersonal skills and ability to work in a team environment.
Strong written and verbal communication.
Strong organization and time management
Proficient in MS Word, Excel, PowerPoint
Through knowledge of cGMP regulations
Experience directly managing employees
Preferred Qualifications:
Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, validation, and process development.
Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
Ability to interpret Quality standards for implementation and review.
WORKING CONDITIONS AND PHYSICAL DEMANDS
Ability to lift up to 30 lbs.
Ability to work one weekend day.
Rotating holiday coverage.
Ability to gown and gain entry to the manufacturing 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.