Pay rate: $20/hr
Monday- Friday 9:00am-5:30pm Occasional OT at end of shift
Responsible for hands-on execution of all activities in the manufacturing area including the processing and packaging of human tissue products for transplantation. All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs). The candidate should have a commitment to high standards of quality
? Follow batch production records (BPRs) and SOPs to manufacture human tissue products.
? Utilize good documentation practices.
? Assist in the preparation of reports and other documentation as applicable to the scope of operations in the manufacturing facility.
? Identify areas for improvement in manufacturing efficiencies and compliance.
? Assist with technology transfer from R&D to manufacturing environment.
? Perform cleaning and preparation of all equipment necessary for the daily manufacturing of products.
? Conduct training sessions for less experienced technicians to ensure a high level of effectiveness and quality is met during production operations.
? Maintain appropriate inventories of supplies within the production area.
? Become an expert in selected key areas of interest.
? Perform housekeeping and general upkeep throughout the production area as required
? Ability to interact professionally at multiple levels
? Excellent organizational, written, and verbal communication skills
? Ability to manage multiple tasks and prioritize workload
? Ability to work professionally with highly confidential information
? Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills
? Ability to work consistently in a fast-paced environment
? Able to handle high pressure situations and constructively resolve potential conflicts
Education and Training/Certification
? Associates degree in a life science
? 1 – 2 years of relevant experience in a GMP environment
? Additional GMP experience may be substituted for educational experience. Preferred:
? Bachelor’s degree in a life science
Related Work Experience
? Familiar with aseptic technique
? Ability to perform mathematical calculations
? Strong interpersonal skills and the ability to work effectively and efficiently in a team environment.
? Excellent oral and written communication skills.
? Ability to work flexible hours including overtime and weekends.
Material & Equipment Used & Frequency
? Computer – Daily
? Autoclave – Daily
? Heat Sealers - Daily
? Lyophilizer – Weekly
Work Environment / Travel Requirements
? Office Environment
? Cleanroom Environment
? Laboratory Environment
? 0% Travel
? Must be able to stand for up to 4 hours at a time
? Must be able to remain in PPE in a cleanroom environment for up to 8 hours.
? Must be able to lift 30 pounds repeatedly
? Must have manual dexterity sufficient to cut finely with a scalpel
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