New Jersey Staffing
Director Sterile & Microbiological Quality Assurance
New Jersey Staffing, Rahway, New Jersey, us, 07065
Job Title: Director, Microbiological Quality and Sterility Assurance (MQSA)
Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, vaccine manufacturing and/or microbiology laboratories for assigned topics. Primary activities include, but are not limited to: Leads the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our manufacturing division is compliant to cGMPs for these topics. Leads divisional projects across internal and external sites. Leads team in development of strategy and assigning project and site support for MQSA. Education Minimum Requirement and Experience: Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with ten (10) years' experience in sterile pharmaceutical industry. OR Master of Science (MS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with eight (8) years' experience in sterile pharmaceutical industry. OR PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with six (6) years' experience in sterile pharmaceutical industry. Required Experience and Skills: Broad experience in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods. Experience in transforming GMP compliance. Excellent spoken and written English. Demonstrated ability to effectively work hands-on with shop floor personnel. Good teacher. Expert knowledge of three or more microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods. Expert knowledge of international GMPs and quality management requirements of various regulatory agencies that may include US FDA, EMEA, TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA and PMDA. Knowledge of USP and EU compendia and ISO industry standards. Quality risk management. Expert knowledge of topics related to sterile, non-sterile, or biologic processing and/or microbiology methods including contamination control. Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses. Excellent spoken and written English. Demonstrates strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position. Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control. Expert knowledge of international GMPs and quality management requirements of various regulatory agencies such as US FDA, EMEA, TGA, ANVISA, and PMDA. Knowledge of USP and EU compendia and ISO industry standards. Quality risk management knowledge and experience. Preferred Skills: External involvement in industry organizations and groups is desirable. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the company has determined the job requirements cannot be reasonably met working remotely. Please note, this hybrid work model guidance also does not apply to roles that have been designated as "remote". Salary Range: $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Requisition ID: R358515
Director, Microbiological Quality and Sterility Assurance (MQSA) is responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, vaccine manufacturing and/or microbiology laboratories for assigned topics. Primary activities include, but are not limited to: Leads the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our manufacturing division is compliant to cGMPs for these topics. Leads divisional projects across internal and external sites. Leads team in development of strategy and assigning project and site support for MQSA. Education Minimum Requirement and Experience: Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with ten (10) years' experience in sterile pharmaceutical industry. OR Master of Science (MS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with eight (8) years' experience in sterile pharmaceutical industry. OR PhD in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, Chemical Engineering, or related science discipline with six (6) years' experience in sterile pharmaceutical industry. Required Experience and Skills: Broad experience in microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods. Experience in transforming GMP compliance. Excellent spoken and written English. Demonstrated ability to effectively work hands-on with shop floor personnel. Good teacher. Expert knowledge of three or more microbiology topics related to sterile, non-sterile, or biologic processing and/or microbiology methods. Expert knowledge of international GMPs and quality management requirements of various regulatory agencies that may include US FDA, EMEA, TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA and PMDA. Knowledge of USP and EU compendia and ISO industry standards. Quality risk management. Expert knowledge of topics related to sterile, non-sterile, or biologic processing and/or microbiology methods including contamination control. Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses. Excellent spoken and written English. Demonstrates strong leadership capabilities and ability to work cross functionally to develop solutions and champion a position. Demonstrated ability to effectively work hands-on with shop floor personnel. Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control. Expert knowledge of international GMPs and quality management requirements of various regulatory agencies such as US FDA, EMEA, TGA, ANVISA, and PMDA. Knowledge of USP and EU compendia and ISO industry standards. Quality risk management knowledge and experience. Preferred Skills: External involvement in industry organizations and groups is desirable. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the company has determined the job requirements cannot be reasonably met working remotely. Please note, this hybrid work model guidance also does not apply to roles that have been designated as "remote". Salary Range: $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Requisition ID: R358515