Production Compliance Specialist
3 days ago
We are seeking a highly skilled Production Compliance Specialist to join our team at Omni Inclusive. As a key member of our compliance team, you will be responsible for ensuring that our production processes meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Conduct and manage resolution of deviations, root cause investigations, impact assessments, and CAPAs as a Lead Investigator
- Liaise with various groups and organizations as a Lead Investigator
- Proactively identify and facilitate resolution of obstacles to timely completion
- Proactively manage progression of investigation and CAPA to timely closure
- Lead and participate in cross-functional investigation teams
- Present investigation findings to key stakeholders and site management
- BS in chemical/biochemical engineering, biological sciences, or a related discipline with 1-3 years relevant experience
- Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred
- Demonstrated basic project management skills, including organization, collaboration, multi-tasking, and communication
- Excellent verbal and written communication skills, including ability to present information clearly and concisely
- Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization
- Prior experience with SOPs, cGMPs, and knowledge of working within a regulatory environment
At Omni Inclusive, we offer a dynamic and supportive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
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Quality Assurance Specialist
2 weeks ago
Devens, Massachusetts, United States Axelon Services Corporation Full timeJob Title: QA Operations Specialist Job Summary: Axelon Services Corporation is seeking a highly skilled QA Operations Specialist to join our team in Devens, MA. As a key member of our QA Operations organization, you will be responsible for ensuring the quality of our manufacturing processes and products. Responsibilities: * Perform quality assurance...
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Field Quality Assurance Specialist
4 weeks ago
Devens, Massachusetts, United States Surnise Systems Inc Full timeJob Title: Field QA SpecialistThis role is 100% OnsiteJob SummaryThe Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with Client policies, standards,...
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Field Specialist QA Operations
3 weeks ago
Devens, Massachusetts, United States Joulé Full timeJob Title:Field QA SpecialistLocation:Devens, MAHours/Schedule:Monday - Friday, 2:00 PM - 10:30 PM ESTType:ContractAs a Field QA Specialist at Joulé, you will be responsible for ensuring manufacturing compliance with applicable procedures and batch records. You will perform real-time reviews of manufacturing batch records and review manufacturing shop floor...
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Production Operator
1 week ago
Devens, Massachusetts, United States Eastridge Full timeJob SummaryEastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities.We are currently seeking a Production Operator to join our team at a medical device company. The successful candidate will be responsible for performing a variety of routine...
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Field Operations Specialist
4 weeks ago
Devens, Massachusetts, United States Joulé Full timeJob Title: Field QA SpecialistLocation: Devens, MAHours/Schedule: Monday to Friday, 2:00 PM to 10:30 PM ESTType: ContractAbout the Role: We are seeking a highly skilled Field QA Specialist to join our team at Joulé. As a Field QA Specialist, you will be responsible for ensuring the quality of our products and services. You will work closely with our...
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Production Manager
1 week ago
Devens, Massachusetts, United States Veranova L P Full timeJob SummaryVeranova L P is seeking a highly skilled Production Supervisor to oversee the daily activities of the Production staff, ensuring the cost-effective and timely delivery of high-quality products. The ideal candidate will have a strong background in API manufacturing, excellent leadership skills, and a solid understanding of GMP and FDA...
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Field Quality Assurance Specialist
4 days ago
Devens, Massachusetts, United States Surnise Systems Inc Full timeJob Title: Field Quality Assurance SpecialistThis role is responsible for ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.Responsibilities:Ensure manufacturing compliance with...
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Field Quality Assurance Specialist
3 weeks ago
Devens, Massachusetts, United States Surnise Systems Inc Full timeJob Title: Field Quality Assurance SpecialistThis role is responsible for ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.Responsibilities:Ensure manufacturing compliance with...
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Product Quality Lead
3 weeks ago
Devens, Massachusetts, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome life-threatening diseases. We are seeking a highly skilled and experienced Product Quality Lead to join our team in Seattle, WA.About the RoleThe Product...
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Field Specialist QA Operations
4 weeks ago
Devens, Massachusetts, United States Joulé Full timeJob Title: Field QA SpecialistAt Joulé, we are seeking a highly skilled Field QA Specialist to join our team. As a Field QA Specialist, you will be responsible for ensuring manufacturing compliance with applicable procedures and batch records.Responsibilities:Perform QA on the floor activities.Ensure manufacturing compliance with applicable procedures and...
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Production Manager
2 days ago
Devens, Massachusetts, United States Randstad Full timeJob Summary:Randstad is seeking a seasoned Production Manager to lead a team in a 24-hour production environment. The ideal candidate will have 10+ years of experience in supervisory roles, with a focus on continuous improvement and lean manufacturing principles.The successful candidate will be responsible for managing shift supervisors and their teams,...
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Procurement Specialist
3 weeks ago
Devens, Massachusetts, United States Omni Inclusive Full timeJob SummaryWe are seeking a highly skilled Procurement Specialist to join our team at Omni Inclusive. As a key member of our procurement team, you will be responsible for managing procure to pay transactions, utilizing SAP Planning (MRP) and Procurement modules to support manufacturing operations, ARIBA to resolve accounts payable invoice issues, and other...
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Field Specialist QA Operations Manager
3 weeks ago
Devens, Massachusetts, United States Integrated Resources, Inc Full timeJob Title: Field Specialist QA OperationsWe are seeking a highly skilled Field Specialist QA Operations to join our team at Integrated Resources, Inc. This role will be responsible for ensuring the quality and compliance of our operations, with a focus on continuous improvement and efficiency.Key Responsibilities:Develop and implement quality initiatives to...
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Field Operations Specialist
3 weeks ago
Devens, Massachusetts, United States Joulé Full timeJob Title: Field QA SpecialistApplying for this role is a straightforward process. Scroll down and click on Apply to be considered for this position.Location:Devens, MAHours/Schedule:Monday to Friday, 2:00 PM - 10:30 PM ESTType:ContractJoin a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines to...
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Tech Support Specialist
3 weeks ago
Devens, Massachusetts, United States Soft-World Full timeJob Title: Tech Support SpecialistJob Description:We are seeking a skilled IT Tech Support Specialist to join our team at Soft-World. The ideal candidate will have experience with ServiceNow and possess strong technical and customer service skills.This role is crucial in ensuring the continuous operation and support of our IT systems during non-standard...
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Packaging Specialist
4 weeks ago
Devens, Massachusetts, United States HW Staffing Solutions Full timeJob SummaryWe are seeking a skilled and detail-oriented individual to join our team as a Packaging Specialist. In this role, you will be responsible for packing plastic products made by thermofoams, ensuring accuracy and quality in every carton.Key Responsibilities:Packing plastic products into cartonsCounting and verifying partsMaintaining a clean and...
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Senior EHS Specialist
3 days ago
Devens, Massachusetts, United States Bristol-Myers Squibb Full timeTransforming Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior EHS Specialist to join our team in Devens, MA.About the RoleThe Senior EHS Specialist will be responsible for ensuring compliance with federal,...
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Quality Control Specialist
4 weeks ago
Devens, Massachusetts, United States Eastridge Workforce Solutions Full timeEastridge Workforce Solutions is seeking a Quality Control Specialist to join a premier medical device manufacturing company. As a Quality Control Specialist, you will play a vital role in maintaining the quality standards of our production processes. Your responsibilities will include conducting routine inspections at various stages of production to ensure...
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Accounts Payable Specialist
3 days ago
Devens, Massachusetts, United States Commonwealth Fusion Systems Full timeAccounts Payable SpecialistCommonwealth Fusion Systems is a pioneering company in the field of commercial fusion energy. We are seeking an experienced Accounts Payable Specialist to join our team. The successful candidate will be responsible for ensuring the timely and accurate payment of bills, coordinating with stakeholders, and maintaining detailed...
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Senior Specialist, Shop Floor Quality Assurance
4 weeks ago
Devens, Massachusetts, United States Bristol-Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Senior Specialist, Shop Floor Quality Assurance to join our team at Bristol-Myers Squibb. As a key member of our Shop Floor Quality Assurance team, you will be responsible for ensuring the highest standards of patient safety, compliance, and operational efficiencies.Key ResponsibilitiesWork in consultation with FQA...