Senior Quality Control Analyst

2 weeks ago

Cambridge, United States Vericel® Corporation Full time

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

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.


DUTIES AND RESPONSIBILITIES

Essential Functions:

  • Perform microbiological, molecular and/or cell culture assays for in-process and final product samples
  • Participate in transfer methodology from other groups and may maintain complex equipment.
  • Author reports, SOPs and other documentation for quality testing and/or equipment.
  • Provide training and technical leadership to less experienced staff.
  • Participate in and/or perform laboratory investigations and non-conformance deviations.
  • Perform finished product review and lot release.
  • May manage departmental projects.
  • Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
  • Exercise judgment and decision making when problem solving
  • Communicate inter-departmentally and with external contracts to solve technical issues.
  • Other duties as assigned


Leadership Responsibilities:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.


QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

  • Bachelor’s Degree + minimum 5+ Years relevant industry experience in CGMP lab environment, or equivalent
  • Master’s Degree + minimum 3+ Years relevant industry experience in CGMP lab environment, or equivalent
  • 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 such as PCR based methodology or cell culture methods.
  • Experience with assay/equipment validations/transfers.
  • Excellent communication skills, verbal and non-verbal desired.
  • 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 ISO 7 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.

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