Training Specialist I - Apligraf

Canton, MA

Job ID: 636

Job Req code: 636

Category: Manufacturing Operations

Job Type: Manufacturing

Under the direction and supervision of the Apligraf Manager, the Apligraf Training Specialist I will support the Apligraf manufacturing department by performing the tasks that will assure the safe and timely processing of the Apligraf product.  The Training Specialist I will ensure that all Apligraf personnel are successfully integrated into the manufacturing environment and are properly trained on all procedures.  

KEY RESPONSIBILITIES

Schedule, perform, and document training of Apligraf production team members.
Maintaining personnel training records.
Aseptic re-qualification & production re-certification of Apligraf production team members.
Initial and re-qualification of gowning in the Class 10K and Class 100 cleanroom. 
Participating in the development and revisions to the Apligraf training program.
Manufacturing Apligraf according to established Master Batch Records and Operating Procedures.
Preparation of all media and sanitizing agents for use within the Production areas.
Adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
Assuring batch records are complete and are compliant with all protocols.
Proper operation of all clean room equipment.
Maintaining all required records and adherence to established guidelines for quality control procedures, GMPs, and safety.  
Basic cleanroom rules and behaviors presentation.


 

Requirements

Excellent communication skills
Demonstrated ability to follow Standard Operating Procedures and work within GMP guidelines
Proficiency in aseptic technique
Ability to assess trainees for aseptic technique proficiency and provide feedback
Cleanroom protocol experience
Dexterity, coordination and some lifting required
Ability to work in a cleanroom environment for extended periods of time
Proficiency with Microsoft Excel and Word 
Ability to work with weights, balances, HLF hood, cleaning procedures, pH meters
Proficiency with Apligraf processing, including aspirating and feeding, sterility sampling, casting and packaging.

EDUCATION AND EXPERIENCE

Required: High school diploma and 1-3 years’ relevant experience. College-level Biology courses with laboratory experience will be considered a plus.
Preferred: Biotechnology certificate or higher (AS, BS) in Biology and 1-3 years’ relevant experience including aseptic technique, GMP and clean room protocols.