Aseptic Processing Team Lead

Direct Hire/Full time
Human Tissue Processing – Team Lead

Class 100 / ISO 5 clean room experience is a must have****

The Human Tissue Processing (HTP) Team Leader will perform the production activities associated with human tissue processing products, under minimal supervision. The Team Leader will adhere to the appropriate SOPs, MBRs, and cGMP procedures in the general lab area as well as the Class 10,000 cleanroom and will be considered a subject matter expert (SME) for the HTP production processes.

Responsibilities:

• Perform all tasks, e.g. Layer separation, cleaning, spreading, cutting, milling, and packaging, for all HTP products with minimal supervision in compliance with Quality Systems regulations and according to established procedure.
• Prepare all media for use within these Production processes with minimal supervision.
  Provide assistance to Engineering and Facilities Departments, as necessary, for equipment operation during calibration, validation, or repair activities.
• Assist with new products, process optimization, and scale-up activities, as necessary.
• Provide assistance with trending and analyzing production data.
• Review batch records for completeness and accuracy as well as compliance with all protocols.
• Maintain all equipment records.
• Perform all tasks adhering to company safety policies.
• Maintain supply inventory as directed by the production schedule.
• Responsible for the writing of deviation and corrective/preventive action reports, as necessary.
• Prepare and update SOPs to ensure documents are current, clear, and accurate.
• Assure compliance with SOPs, clean room protocols, and clean room policies in the clean room suites.
• Perform change control activities, including but not limited to Process Change Orders and Equipment Change Requests as needed.
• Oversee the accurate and timely batch transactions in the ERP System (i.e. Microsoft Dynamics AX).

Job Requirements

• Certificate in Biotechnology preferred, and/or a minimum of 2-5 years of relevant experience or Associates/Bachelors degree in biology or related field with 2-4 years.
• Aseptic technique and clean room protocol experience desired.
• Ability to operate general lab equipment and familiarity with general lab techniques (e.g. balances, pipettes, stir bases, and heat sealers).
• Ability to work in a cleanroom environment for extended periods of time.
• Aseptic techniques and basic knowledge of lab techniques.