Fagron GmbH & CO. KG
Aseptic Cleanroom Supervisor
Fagron GmbH & CO. KG, Boston, Massachusetts, us, 02298
Over de functie
As the Packaging 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. 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, troubleshoot 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. Wat wij vragen
7 years of experience working in a regulated environment with a 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. Wat wij bieden
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to: Competitive Salary Health, Vision, and Dental Insurance Company Paid Life Insurance Generous Paid Holidays Paid Volunteer Time Generous Paid Time Off and Rollover Company matching 401K and Retirement Savings Plans Employee Assistance Program Flexible working arrangements Over het bedrijf
Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions. If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love! Together we create the future of personalizing medicine.
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As the Packaging 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. 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, troubleshoot 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. Wat wij vragen
7 years of experience working in a regulated environment with a 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. Wat wij bieden
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to: Competitive Salary Health, Vision, and Dental Insurance Company Paid Life Insurance Generous Paid Holidays Paid Volunteer Time Generous Paid Time Off and Rollover Company matching 401K and Retirement Savings Plans Employee Assistance Program Flexible working arrangements Over het bedrijf
Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions. If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love! Together we create the future of personalizing medicine.
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