BuildSubmarines.com
MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager.
As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.
Responsibilities:
Provide leadership and expertise on quality assurance processes and toolsLead a team that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Audits, Complaint Management, Supplier Quality, Document Control, Validation, and Data IntegrityEnsure that departments responsible for products meet quality standards and performance goals of MilliporeSigmaEnsure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systemsSupport the site's compliance activities through accurate regulatory recordkeeping and reportingManage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMPHire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goalsDrive achievement of site vision and goals / objectivesDrive risk reduction programs and ensure application of risk management and sound root cause analysisAnalyze and report quality measures, performance, tends and improvementsReview and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure complianceProvide quality assurance support to other site departmentsSupport the site's regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.
Who You Are:
Minimum
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or other Science field 3
years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry2
years of experience in a leadership position Preferred
Qualifications:
5
years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry3
years of experience with progressing increasing responsibilities as a supervisorExperience with quality management systems such as Trackwise, electronic document management system, etc.
Experience with customer audits and regulatory inspectionsAbout the Company:
BuildSubmarines.
comThousands of new roles.
Fifty states.
One mission.
The Navy is on a once-in-a-generation journey to completely transform its nuclear-powered submarine fleet and maintain its critical undersea advantage.
However, this military mandate will require the addition of more than 100,000 skilled workers with the training and commitment to ensure success.
And there's not a moment to spare.
What makes a next-generation submarine? They are the largest and most technologically advanced subs the U.
S.
Navy has ever put to sea.
Nuclear powered, with the endurance to run without refueling for over 40 years.
Range? Unlimited.
These are truly futuristic marvels of design and engineering that will launch our military technology decades into the future.
We need to grow our workforce by 100,000 to meet our objective The magnitude of this mission involves the collaboration of thousands of suppliers and hundreds of thousands of hands, united to construct this modern fleet.
? No ordinary assembly line exists to piece together these giants.
This is a meticulous process, guided by visionaries and craftspeople who design, calibrate, inspect, assemble, and test every inch of these extraordinary vessels.
? And at this moment, we need more.
Company Size:
10,000 employees or moreIndustry:
Government and MilitaryFounded:
0Website:
https:
//www.
buildsubmarines.
com.
Estimated Salary: $20 to $28 per hour based on qualifications.
As a Quality Assurance Manager, you will ensure that the quality assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.
Responsibilities:
Provide leadership and expertise on quality assurance processes and toolsLead a team that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Audits, Complaint Management, Supplier Quality, Document Control, Validation, and Data IntegrityEnsure that departments responsible for products meet quality standards and performance goals of MilliporeSigmaEnsure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systemsSupport the site's compliance activities through accurate regulatory recordkeeping and reportingManage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMPHire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goalsDrive achievement of site vision and goals / objectivesDrive risk reduction programs and ensure application of risk management and sound root cause analysisAnalyze and report quality measures, performance, tends and improvementsReview and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure complianceProvide quality assurance support to other site departmentsSupport the site's regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.
Who You Are:
Minimum
Qualifications:
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or other Science field 3
years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry2
years of experience in a leadership position Preferred
Qualifications:
5
years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry3
years of experience with progressing increasing responsibilities as a supervisorExperience with quality management systems such as Trackwise, electronic document management system, etc.
Experience with customer audits and regulatory inspectionsAbout the Company:
BuildSubmarines.
comThousands of new roles.
Fifty states.
One mission.
The Navy is on a once-in-a-generation journey to completely transform its nuclear-powered submarine fleet and maintain its critical undersea advantage.
However, this military mandate will require the addition of more than 100,000 skilled workers with the training and commitment to ensure success.
And there's not a moment to spare.
What makes a next-generation submarine? They are the largest and most technologically advanced subs the U.
S.
Navy has ever put to sea.
Nuclear powered, with the endurance to run without refueling for over 40 years.
Range? Unlimited.
These are truly futuristic marvels of design and engineering that will launch our military technology decades into the future.
We need to grow our workforce by 100,000 to meet our objective The magnitude of this mission involves the collaboration of thousands of suppliers and hundreds of thousands of hands, united to construct this modern fleet.
? No ordinary assembly line exists to piece together these giants.
This is a meticulous process, guided by visionaries and craftspeople who design, calibrate, inspect, assemble, and test every inch of these extraordinary vessels.
? And at this moment, we need more.
Company Size:
10,000 employees or moreIndustry:
Government and MilitaryFounded:
0Website:
https:
//www.
buildsubmarines.
com.
Estimated Salary: $20 to $28 per hour based on qualifications.
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