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As the Cleanroom Supervisor you will assist pharmacists and room supervisors oversee all required activities for the preparation of materials and manual aseptic filling of compounding sterile products within an ISO 7 environment.
Job Responsibility:
Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms
Successfully pass media fill and remain qualified to assist with tasks within the ISO VLFH as required
Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hrs. per day
Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks and environmental plating of operators
Must be able to rapidly assess situations, trouble shoot production concerns, guide operators, and effectively communicate complex detailed information to management outside of the cleanrooms via electronic tools frequently and quickly
Ensuring compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed
Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections quickly
Review and maintain adherence to the manufacturing schedules
Track employee training to ensure compliance
Aid in bi-annual reviews of procedures
Provide on-the-floor leadership to the production team
Assist in coaching and training of technicians in the manufacturing suites
Support process improvements and scale up initiative within the department
Approve electronic time keeping for reports
Manage personnel to operational standards and complete performance evaluations
Requirements:
7 years of experience working in a regulated environment
Minimum of 3 to 5 years’ experience in a leadership position (i.e., Shift of Line Leader, Group Leader, etc) or demonstrated leadership abilities
Good working knowledge of all functional areas of the inspection and packaging area
Solid math and effective problem-solving skills with demonstrated use of sound judgement
Good communication and organizational skills, strong interpersonal skills
Demonstrated ability to work effectively and lead a team
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management
Ability to take initiative, including asking for and offering help when needed
performs work independently without being prompted
Strong attention to detail and focus on quality, accuracy, and accountability
What we offer:
Competitive salary
Comprehensive benefits
Performance package
Ability to be part of an international leader in an expanding industry