3-5 years of experience in aseptic processing within the pharmaceutical or biotechnology industry.
Strong knowledge of aseptic techniques and regulatory requirements.
Excellent communication and interpersonal skills.
Ability to train and mentor staff effectively.
Problem-solving abilities and a proactive approach to process improvement.
Job Description:
A pharmaceutical company in the Durham, NC area is looking for an Aseptic Coach to support their growing team. The Aseptic Coach is responsible for ensuring that aseptic techniques and practices are consistently applied in the production environment. This role involves training, coaching, and mentoring production staff to maintain the highest standards of aseptic processing, thereby ensuring product safety and quality.
Responsibilities:
Conduct comprehensive training sessions on aseptic techniques, including gowning procedures, environmental monitoring, and cleanroom behavior.
Provide ongoing coaching and support to production staff to reinforce aseptic practices and address any deviations or non-compliance.
Identify areas for improvement in aseptic processes and collaborate with cross-functional teams to implement corrective actions and best practices.
Regularly audit aseptic practices and procedures to ensure compliance with regulatory standards and company policies.
Maintain accurate records of training sessions, audits, and corrective actions. Prepare reports and documentation for regulatory inspections.
Investigate and resolve issues related to aseptic processing, working closely with quality assurance and production teams.
Serve as a liaison between production staff and management, providing updates on training progress, compliance issues, and process improvements.