MIMEDX is looking to ensure compliance with standard operating procedures (SOPs) and applicable regulations in the manufacture of their regenerative biologics, and to determine the acceptability of new and returned products for release and disposition.
Requirements
- Prefer knowledge of AATB, FDA, and other state/federal regulations
- Proficient in Microsoft Office (Excel, Word, etc.)
Responsibilities
- Review documentation records within the CEA completed by technicians during processing of any/all products to ensure proper procedures were followed
- Identify any errors/deviations in processing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed
- Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product
- Inspect the condition of all returned products and determine final disposition (e.g. can it be returned to inventory, does it require re-packaging, should it be discarded as waste, etc.)
- Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable
- Make final determination of product availability (new and returned goods) for use; move product both physically and electronically (e.g. inventory database) from packaged goods quarantine room/returned product quarantine to release product storage room
- Reconciliation of processing records for technician documentation of donor processing
Other
- Will review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP’s) and applicable regulations.
- Inspect all new products and determine their acceptability for release for distribution/shipment; inspect returned products to make final disposition determination.
- Work to resolve identified errors and deviations, review and maintain applicable records, and ensure compliance with quality system standards, policies, and procedures.
- Bachelor’s degree in related field or equivalent work experience
- Excellent oral, written, and interpersonal communication skills
