Training Specialist
Vericel® Corporation
full-time
Posted on:
Location Type: Office
Location: Burlington • Massachusetts • United States
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Salary
💰 $27 - $34 per hour
About the role
- Train technicians to execute the specific process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
- Deliver cGMP, technical training which includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment.
- Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs.
- Demonstrate to new staff how to perform manufacturing procedures inside an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs and safety regulations.
- Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
- Work with the Manufacturing team to evaluate personnel training needs.
- Coordinate new hire manufacturing training with Manufacturing Management and the Training Department as required to ensure assignment and completion in LMS.
- Coordinate cross training of existing staff with Manufacturing Management.
- Assist in reviewing and revising documents as a result of deep understanding of manufacturing processes.
- Assist in deviation investigations, CAPAs, risk assessments and change controls.
Requirements
- Bachelor's degree with at least 2 years of experience working in a cGMP environment in the biotech or pharmaceutical industry
- Biotechnology certificate with 4+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry
- Mastery of Vericel’s Manufacturing procedures – Minimum of 2 years of successful Vericel Manufacturing Process Experience
- Demonstrated success as a Qualified Trainer for at least three (3) aseptic processing operations
- Proven ability to provide feedback in a coaching manner while maintaining the integrity of the SOP and regulatory requirements
- Strong experience with PowerPoint, Word and Excel.
- Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Ability to work 1 weekend day.
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas.
Benefits
- Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
cGMPISO Class 7 cleanroommanufacturing proceduresaseptic processing operationsdeviation investigationsCAPAsrisk assessmentschange controlstraining developmentbatch records
Soft Skills
coachingorganizational skillsplanning skillsteam cooperationfeedback provision
Certifications
Bachelor's degreeBiotechnology certificate