Manager, Sterility Assurance
Scorpion Therapeutics
Responsibilities Oversee and drive continued compliance of the site contamination control program. Ensure execution/support of contamination control strategy (aseptic processes; facility design/modification; gowning certification/recertification; environmental monitoring; clean utility systems; EMPQs). Ensure sterility assurance activities comply with regulatory requirements (FDA, EMA, USP) and BMS policies. Serve as Sterility Assurance SME for projects, continuous improvement, and Quality Risk Management. Own/review eQMS documentation (document revisions, change controls, deviations, CAPAs) and act as SME. Support EM/CU metrics and data analysis (EM/CU trends, capacity ramp reports). Oversee environmental monitoring, clean utility monitoring, aseptic process simulation, aseptic performance qualification, aseptic observer, and aseptic gowning programs. Support validations/qualifications (equipment, facility, microbiological methods), Environmental Action Committee governance, and regulatory filings. Perform final review of root cause analyses for EM deviations; support inspections and regulatory inquiries; support manufacturing/production triage meetings; participate in global forums. Qualifications Advanced microbiology and aseptic processing knowledge. Experience with QC microbiology and EM/CU monitoring (procedures, techniques, lab methods; EM/CU program development). Knowledge of facility control systems (HVAC, utilities, DPs, cleaning/disinfection) and US/EU cGMP. Apply ICH Q9 quality risk management; proficiency with SOPs, change control, deviations, CAPAs. Strong troubleshooting/investigation and communication; team-oriented, works independently cross-functionally. STEM bachelor’s preferred; minimum 6 years in cGMP environment (preferably 3+ years in QC microbiology and/or sterility assurance). Cell therapy manufacturing knowledge highly desirable. Benefits Health coverage Wellbeing support 401(k) and insurance/disability Paid time off (flexible time off or annual vacation/holidays by location) On-site/other: occasional on-call, routine gowning in manufacturing cleanroom; occasional travel may be required. #J-18808-Ljbffr Scorpion Therapeutics
$260.86k - $316.1k
...Position Summary The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's... ...and executive-level reporting cadence CMO & External Partner Management Support any implementation of BMS's Sterility Assurance...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$100.48k - $121.76k
...their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .Position SummaryThe Manager, Sterility Assurance role is responsible for overseeing and driving continued compliance of the site contamination control program. This includes...SuggestedHourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...the careers of those who do it. Position Summary The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people leader. The... ...investigations, and CAPA management. Preferred: experience in aseptic/sterile environments or quality control focused on microbial...SuggestedSummer workLive inRemote workMonday to FridayFlexible hoursShift workNight shiftRotating shiftAfternoon shift
$100k - $125k
...designed systems. Position Summary Renaissance Electronics is looking to add a Supplier Development and Quality Assurance Manager to join the team. This role will develop and maintain quality systems, drive supplier performance improvement, and strengthen...SuggestedFull timeAEM
Harvard, MA1 day ago$200k - $220k
...Director, Design and Supplier Quality Assurance to join their team! Hybrid schedule 1-2... ...product) Validation (CSV), labeling and sterilization compliance, and periodic/ad-hoc risk reviews... ...industry with at least 12 years in a management/leadership role in quality / regulatory...SuggestedFull time$105k
...Description Job Description Adecco Staffing is hiring a Quality Assurance Supervisor for a manufacturing site in Devens, Massachusetts.... ...and release products while enforcing quality standards Manage incoming material inspection processes Develop QC procedures...Permanent employmentFull timeLocal areaMonday to FridayShift workDay shiftAdecco
Devens, MA2 days ago$173.28k - $209.98k
...consistently meet regulatory requirements, internal Quality Management System (QMS) standards, and inspection readiness... ...activities, including environmental and utility monitoring, sterility assurance, microbial testing, and microbiological release support. Establish...Hourly payContract workTemporary workSummer workFlexible hours$55k - $60k
...expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases. At... ...nutrition for patients and consumers. Job Summary The Product Quality Assurance Coordinator (Vitamins/Supplements) will facilitate and...Work experience placementMonday to Friday- ...monitoring applications for defense, industrial, and commercial customers worldwide. We have an exciting opportunity for a Quality Assurance Manager to join our team in Acton, MA! This position typically reports to a senior manager and is responsible for the planning,...Full timeContract workPart timeLocal areaWorldwideRelocation package
General Atomics
Acton, MA4 days ago - Job Responsibilities Responsible for coordination, implementation, and maintenance of QA Program. Supervise daily QC Technician Activities. Responsible for identifying quality and food safety issues & verify they have been corrected. Conduct internal, 3rd party and ...
- ...is for you! We are now hiring for a Full-Time, Branch Manager for our rapidly expanding Electrical Supplies business. This position... ...and attention to detail while also emphasizing safety, quality assurance and efficiency. Individual needs to be highly self-motivated,...Full timeLocal areaImmediate startMonday to FridayFlexible hours
Green Mountain Electric Supply
Still River, MA4 hours ago - Food Safety Qaulity & Assurance Manager job at Gpac. Leominster, MA. gpac is working with a food manufacturer in Central Massachusetts seeking an experienced FSQA (Food Safety & Quality Assurance) Manager with a strong background in quality assurance, seafood processing...Immediate startFlexible hoursShift work
$104.98k - $127.21k
...better place than here at BMS with our Cell Therapy team. The Manager, Cell Therapy Manufacturing supports the commercial operations... ...and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a...Hourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workBristol-Myers Squibb
Devens, MA14 hours ago$40.16 - $48.67 per hour
....bms.com/working-with-us . Position Summary The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration... ...effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy....Hourly payFull timeTemporary workPart timeFor contractorsWork experience placementSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workDay shiftBristol-Myers Squibb
Devens, MA3 days ago- A leading electronics manufacturer in Harvard, MA seeks a Supplier Development and Quality Assurance Manager. The role focuses on developing and maintaining quality systems while driving supplier performance and supporting operational excellence. Candidates should have...Full time
$89.78k - $108.79k
...careers.bms.com/working-with-us . The Sr. Specialist, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is... ...preparing deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP), ensuring...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workDay shiftBristol-Myers Squibb
Devens, MA2 days ago$89.78k - $108.79k
Position Summary The Quality Assurance Shop Floor team is responsible for 24x7 quality collaboration and oversight of site operations,... ...to complex issues independently, escalating critical issues to management. Perform and document operational verification per approved...Full timeTemporary workWork experience placementSummer workFlexible hoursDay shift- ...of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. Reports to the Shift Manager, Quality Assurance Shop Floor. Rotating 2-3-2 Panama schedule (6am to 6pm) Day shift. Key Responsibilities Provide Quality on‑floor...Temporary workWork experience placementShift workDay shift
$40.16 - $48.67 per hour
...Description Bringing your expertise to Bristol Myers Squibb’s Quality Assurance Shop Floor team will enable you to support the 24/7 quality... ...prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy....Hourly payFull timeWork experience placementShift workDay shift- VulcanForms Inc. is seeking a Staff Technical Program Manager for New Customer Development in Ayer, Massachusetts. The role involves managing multiple customer development programs from initial contact to part qualification while partnering with various engineering teams...
$111k - $153k
VulcanForms Inc. in Harvard, Massachusetts is seeking a Staff Technical Program Manager for New Customer Development. The candidate will manage multiple customer programs, collaborating closely with various engineering teams. This role requires 8+ years of experience in...$111k - $153k
...continuously learn, because we believe diverse perspectives lead to better outcomes. Job Purpose As a Staff Technical Program Manager, New Customer Development at VulcanForms Inc., your main objective is to manage multiple customers' portfolio of programs from...VulcanForms Inc.
Devens, MA14 hours ago- ...hear from you. Join the power movement as Project Engineering Manager Leading a team responsible for activities relating to design... ...Review material receiving reports and warehousing to assure delivery of correct materials Coordinate the preparation of...Full timeFor contractorsFor subcontractorFlexible hoursNight shiftWeekend work
Commonwealth Fusion Systems
Devens, MAmore than 2 months ago $89.78k - $108.79k
...Bristol Myers Squibb is seeking a Senior Specialist for Quality Assurance Investigations at the Devens Cell Therapy Facility. This role oversees Deviations and ensures compliance with all regulations and internal policies. The ideal candidate will hold a Bachelor’s degree...Bristol-Myers Squibb
Harvard, MA22 hours ago$95k - $130k
...innovative solutions? At HOERBIGER, we are looking for bright minds who want to drive technological progress forward. As our Quality Manager, you will lead quality improvement initiatives, ensure customer satisfaction, and foster a culture of quality across the...Temporary workRemote workFlexible hoursHoerbiger
Still River, MA8 hours ago$72.65k - $103.9k
...Job Responsibilities Daily Planning, Execution and Area Management: • Performs pre-shift task planning and prioritization activities... ...causes for any misses. Implements corrective actions. • Assures team members understand department performance goals and work...Permanent employmentContract workWork experience placementLocal areaFlexible hoursShift workAfternoon shiftLeonardo DRS
Fitchburg, MA14 hours ago- ...team. Candidates should have 7-10 years of industry experience, particularly in high volume settings, and demonstrate expertise in managing production teams and data-driven decision-making. A full range of benefits is offered, including medical, dental, and 401(k)...Flexible hours
$89.78k - $108.79k
...careers.bms.com/working-with-us. The Sr. Specialist, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is responsible... ...deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP), ensuring...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift workDay shift$54 - $56.42 per hour
...subject matter expertise • Excellent computer skills and proficiency with MS Office is required. • Contacts are primarily with Quality Assurance and QC operations, as well as Clinical Manufacturing. This posting is for a contract assignment with ASK Staffing DBA ASK...Hourly payContract workTemporary workFor contractorsLocal areaShift workNight shift$66 - $70 per hour
...Overview: This position will regularly interact with: Reporting Manager. Sometimes will interact with departments listed below: Quality... ...Rate: $66.00-$70.00/Hour Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through...Contract workRemote workRotating shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Manager, Sterility Assurance. Be the first to apply!
- analysis manager Harvard, MA
- drafting manager Harvard, MA
- e-learning manager Harvard, MA
- automation manager Harvard, MA
- manager corporate partnerships Harvard, MA
- mission manager Harvard, MA
- experience manager Harvard, MA
- pharma manager Harvard, MA
- foundation manager Harvard, MA
- senior manager automotive Harvard, MA