Plans and conducts activities concerned with quality control, quality assurance and compliance of allograft processing.

• Adheres to Good Tissue Practices established by FDA 1271 part 20, AATB Standards, EU GMP Annex I as well as quality/company objectives (goals) and corporate policies.
• Creates and updates procedures for the Allograft QMS that meet regulatory requirements.
• Completes deviations and CAPAs by providing a report that includes root cause, correction and corrective action.
• Analyzes and reports quality system and product specific data (trending) to the quality and processing team.
• Audits QMS and allograft processing to confirm compliance with procedures used and regulatory requirements.
• Updates the quality system based on non-conformities found during internal and external audits.
• Completes product and process validation, re-validation work which includes equipment and aseptic processing.
• Trains personnel to aseptic techniques and contamination control.
• Leads product and process risk evaluations.
• Applies statistical techniques to product and process.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Performs review and evaluation of supplier quality information to qualify the vendors.
• Completes product complaint investigation and initiation of any corrections or corrective actions.
• Manages and improves assigned areas within the Quality Management System (QMS) including SOPs, work instructions, inspections.
• Provides support during QMS audits.
• Adheres to company policies, procedures, and documentation requirements.
• Treats others with courtesy, sensitivity, and respect at all times.
• Other duties as assigned.

Bachelors99 degree in either Biology, Microbiology, Chemistry, Chemical Engineering, Mechanical Engineering, or Biomedical Engineering required

6 years99 related experience

Knowledge of biologics/tissue processing preferred

Microsoft Office.

Fluent in English.