Fagron GmbH & CO. KG
Cleanroom Supervisor
Fagron GmbH & CO. KG, Boston, Massachusetts, us, 02298
Over de functie
About the role As the Cleanroom Supervisor you will work alongside pharmacists, other room supervisors and senior technicians to oversee all required activities for the preparation of materials and manual aseptic filling of compounded sterile products in an ISO 5 VLFH within an ISO 7 environment. Key Responsibilities · Successfully pass and remain gowning qualified for entrance into the ISO 7 cleanrooms. · Successfully pass media fill and remain qualified to assist with tasks within the ISO 5 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 monitoring 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.
Wat wij vragen
Basic Qualifications · Minimum of 3 years of experience working in a regulated/GMP environment with a minimum of 1 year experience in a leadership position (i.e., Shift of Line Leader, Group Leader, etc) or demonstrated leadership abilities. · Minimum of 1 year ISO 7 cleanroom experience, ISO 5 experience a plus · Good working knowledge of appropriate cleanroom behavior and aseptic technique. · Solid math and effective problem-solving skills with demonstrated use of sound judgement. · Good communication, verbal and electronic, and organizational skills, strong interpersonal skills. · Demonstrated ability to work effectively and lead a team. Core Competencies · 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.
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 Now let's not forget our site! The FSS Boston facility is in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility. The employee breakroom provides plenty of storage for lunches and you can enjoy free coffee anytime of the day! Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
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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About the role As the Cleanroom Supervisor you will work alongside pharmacists, other room supervisors and senior technicians to oversee all required activities for the preparation of materials and manual aseptic filling of compounded sterile products in an ISO 5 VLFH within an ISO 7 environment. Key Responsibilities · Successfully pass and remain gowning qualified for entrance into the ISO 7 cleanrooms. · Successfully pass media fill and remain qualified to assist with tasks within the ISO 5 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 monitoring 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.
Wat wij vragen
Basic Qualifications · Minimum of 3 years of experience working in a regulated/GMP environment with a minimum of 1 year experience in a leadership position (i.e., Shift of Line Leader, Group Leader, etc) or demonstrated leadership abilities. · Minimum of 1 year ISO 7 cleanroom experience, ISO 5 experience a plus · Good working knowledge of appropriate cleanroom behavior and aseptic technique. · Solid math and effective problem-solving skills with demonstrated use of sound judgement. · Good communication, verbal and electronic, and organizational skills, strong interpersonal skills. · Demonstrated ability to work effectively and lead a team. Core Competencies · 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.
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 Now let's not forget our site! The FSS Boston facility is in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility. The employee breakroom provides plenty of storage for lunches and you can enjoy free coffee anytime of the day! Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
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.
#J-18808-Ljbffr