Quality Assurance Specialist, I jobs in United States
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Vericel® Corporation · 6 hours ago

Quality Assurance Specialist, I

Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care, focusing on innovative treatments. The Quality Assurance Specialist, I will be responsible for batch record review, media disposition, and inspection of final products within an ISO 7 cleanroom environment.

BiotechnologyLife ScienceTherapeutics

Responsibilities

Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs
Responsible for the packaging and final batch disposition
Responsible for inspection of final product within an ISO 7 cleanroom
Support day to day operations, including batch record review, label issuance, archiving and verification with supervision oversight and in a timely manner
Follow oral and written procedures for review and release of intermediate and final product
Support projects as a QA resource
Identifies deficiencies and works with cross functional departments to remedy them
Identifies issues and provides recommendations for process improvements within the department
Revise Standard Operating Procedures
Other duties as assigned

Qualification

GMP regulationsISO 7 cleanroomElectronic batch recordsQuality Management SystemsMS WordExcelCommunication skillsOrganization skillsTime management skills

Required

High School degree/GED with 2 years of relevant pharmaceutical/biotech experience or Bachelors plus 0-1 years of relevant pharmaceutical/biotech experience
Basic working knowledge of GMP regulations
Ability to lift and transport up to 30 lbs
Must be able to work one weekend day
Must be able to support rotating holiday coverage
Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product
Must be able to gown into CNC areas

Preferred

Strong written and verbal communication skills
Strong organization and time management skills
Proficient in MS Word and Excel
Experience with electronic batch records, ERP systems and Quality Management Systems (Examples: TrackWise and Veeva)

Benefits

Bonus
Incentive pay
Equity
Benefits

Company

Vericel® Corporation

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Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets.

Funding

Current Stage
Public Company
Total Funding
$157.3M
Key Investors
Eastern Capital
2018-06-07Post Ipo Equity· $74.8M
2016-12-16Post Ipo Equity· $20M
2012-03-09Post Ipo Equity· $40M

Leadership Team

J
Jonathan Siegal
Vice President and Corporate Controller
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Karen Mahoney
Chief Human Resources Officer
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Company data provided by crunchbase