Senior Stability Specialist - GMP & Regulatory Expert
Socket.dev
SHINE Technologies in Massachusetts is seeking a GMP Senior Stability Specialist to serve as the technical SME for stability programs, coordinating, executing, and monitoring activities in line with cGMP and regulatory requirements. This role requires on-site presence five days a week and partners with QC, QA, Manufacturing, and Regulatory Affairs. You will design and maintain stability studies, assess data, provide shelf-life recommendations, lead investigations, approve protocols and reports, #J-18808-Ljbffr Socket.dev
$110k - $125k
Description General Purpose of the job: The GMP Senior Stability Specialist serves as the technical subject matter expert for GMP stability programs and is responsible... ...Practices (cGMP) and applicable regulatory requirements (e.g., ICH, FDA). The Senior Stability...SeniorRegulatoryFlexible hoursShift work$152.34k - $238.28k
...employee-owners. This opportunity entails serving as a technical expert in wetland and waterways permitting for complex infrastructure... ...role focuses on applying environmental planning strategies, regulatory knowledge, and technical expertise to support permitting, compliance...SeniorRegulatoryFull timeWork at officeLocal area- Progress Software Corporation is seeking a Senior Workday HRIS Specialist to join our Human Resources team in a role focused on managing Workday, Recruiting, Benefits, and Payroll systems. You will drive HRIS projects, ensure data integrity, and partner with IT and vendors...Senior
$127k - $172k
...hindered by the burden of disease.DescriptionThe Senior IT Business Analyst, GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) Systems Manager is... ...partnership to Quality Assurance (QA) and Regulatory Affairs/Regulatory Operations (RA/Reg Ops) teams...SeniorRegulatoryTemporary workSummer workWork at officeLocal area- ...medical technology manufacturer developing advanced proton therapy systems. We are seeking a Senior EHS Specialist / Supervisor to own our site EHS programs, ensure regulatory compliance, and drive a proactive safety culture. Key Responsibilities Compliance &...SeniorRegulatoryLocal areaRelocationFlexible hours
- Workers Credit Union, headquartered in Littleton, MA, is seeking a Senior Mortgage Underwriter to assess and approve first mortgage and home equity loan applications within policy, investor, and regulatory requirements. In this hybrid role, you will mentor junior...SeniorRegulatory
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight... ...compliance with global regulatory requirements and... ...serve as a subject matter expert in GMP quality systems, CMC quality... ..., validation reports, stability reports, investigations,...SeniorRegulatoryFull timeContract workImmediate start
- ...because we believe people power progress. Join us as a HRIS Specialist, Senior Principal and help us do what we do best: propelling business... ...supporting a global workforce across multiple regions and regulatory environments. Experience operating within a shared services...SeniorRegulatoryCasual workWork at officeShift work2 days per week
- ...because we believe people power progress. Join us as a HRIS Specialist, Senior and help us do what we do best: propelling business forward.... ...teams. Ensure data accuracy, integrity, and compliance with regulatory and company standards. Partner with the payroll team to...SeniorRegulatoryCasual workWork at office
$154.4k - $242.55k
...Job DescriptionJoin Takeda as a Senior/Principal Scientist, Cell Based-... ...Potency Assay Development. As an expert professional within the... ...characterization, process development, GMP release and stability testing, comparability, regulatory submissions, and analytical control...SeniorRegulatoryMinimum wageContract workTemporary workLocal area$75.3k - $150.7k
...get on with their lives. This position of Senior Specialist, Product Performance works within our Quality... ...handling and is process owner for clinical and regulatory decision making. This role will be the subject matter expert, work closely with Commercial, Operations,...SeniorRegulatoryWorldwideShift work$20 - $23 per hour
...Services Location: Lowell, MA - Clinical Stabilization Services (CSS) Inpatient Treatment... .../entertainment nationwide The Recovery Specialist is responsible for: Maintaining a safe... ...setting with clients, families, staff and regulatory agencies. Must have basic ability in use...RegulatoryHourly payFull timeFlexible hoursShift workDay shift- ...engineering methodologies, systems and practices to meet customer and regulatory requirements.Key DutiesProvide expertise in Risk Management,... ...Word, Excel, PowerPoint) Extensive working knowledge of GMP, FDA regulations (21 CFR Part 820), ISO 13485 Ability to write,...SeniorRegulatoryFor subcontractorWork at office
$17 - $27 per hour
...our culture supports their growth and stability. They are challenged and driven by an incredible... ...: We are seeking a Production Specialist who thrives in a collaborative, team-... ...all production activities meet safety, regulatory, and company standards · Assist in implementing...RegulatoryHourly payPermanent employmentRemote workMonday to Friday$160k - $200k
...experienced Associate Director, GMP Quality Assurance Operations... ...in compliance with global regulatory requirements, company quality... ...expectations.Reporting to the Senior Director, Quality. This role... ...CPV, OOS/OOT management, and stability programs, ensuring timely and...RegulatoryWork at officeRemote work- A leading staffing firm in Tewksbury is seeking an Environmental Health & Safety Specialist to support compliance with safety regulations and manage hazardous waste. The ideal candidate has a Bachelor’s degree and 1-2 years of experience in environmental health and safety...Contract work
$89.9k - $141.24k
...knowledge.Job DescriptionJoin Takeda as a Senior Research Associate, Analytical... ...product understanding, comparability, stability, and regulatory submissions. You will independently plan... ...integrity, good documentation practices, GMP awareness, and compliance with...SeniorRegulatoryMinimum wageTemporary workLocal areaShift work- ...Pharmaceutical Industries, Inc (USA) seeks a Manufacturing Operations and Compliance Specialist to support compliance activities within the manufacturing organization, ensuring adherence to GMP, regulatory requirements, and quality standards. This role partners with Manufacturing...Regulatory
$80k - $100k
...range of $80,000 to $100,000, this role not only offers financial stability but also the chance to contribute to meaningful change in the... ...documentation that aligns with ethical standards and regulatory requirements, ensuring client confidentiality and care continuity...RegulatoryRemote jobFull timeImmediate startFlexible hours$172k - $192k
...Senior Manager, Quality ControlBedford, Massachusetts, United StatesStoke Therapeutics... ...for overseeing all aspects of GMP testing and supporting stability program management for Stoke' IMPs... ...Sr. Manager, QC is accountable for regulatory inspection interactions related to...SeniorRegulatoryContract workTemporary workWork at office- ...AECOM is seeking a creative, senior Air Quality Project Manager to lead air permitting and compliance initiatives from our Chelmsford... ...hybrid work options. This role supports the air permitting and regulatory programs across client projects. Key responsibilities include developing...SeniorRegulatoryWork at office
- Raytheon is seeking a Senior Cyber Enhanced Assessment (CEA) Assessor II to support multiple facilities, primarily onsite in Andover, MA / Tewksbury, MA / Woburn, MA. The role focuses on enhanced assessment activities, compliance validation, and mentoring cybersecurity...Senior
- Bruker is seeking a Senior Order Coordinator for the Biosystems Order Management Team in Billerica, MA. You will process customer orders, convert quotes to orders, and ensure timely invoicing while maintaining revenue recognition compliance. The role requires SAP ERP experience...Senior
$72k - $120k
A leading analytical instrumentation company is seeking a Senior Revenue Recognition Accountant to manage month-end close processes and ensure compliance with US GAAP. The ideal candidate will have a Bachelor's degree in accounting or finance, at least 3 years of revenue...Senior$100k - $115k
Job Title:Senior Specialist, Supply ChainJob Description:The RoleEntegris is seeking an experienced Senior Specialist, Supply Chain to manage and resolve supply chain escalations within the Advanced Purity Solutions (APS) Division. In this role, you will partner with global...SeniorFull timeH1bWork at office- ...team that wins.Job DescriptionWe are seeking an Export Licensing Specialist to support U.S. export licensing activities under the Export... ...to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics...RegulatoryMinimum wagePermanent employmentFull timeWork experience placementLocal area
$122.7k - $184.1k
...foundation of life-changing medicines. As a Senior Principal Biostatistician within the... ...will serve as a Statistical Subject Matter Expert at the Global or Regional Program study... .... From early development through regulatory submission and lifecycle management, your...SeniorRegulatoryContract workWorldwideFlexible hours- Baker Tilly is seeking a Senior Consultant (Life Sciences - Compliance) to join its Risk Advisory practice. You will work on a variety... ..., including compliance program development, data analysis, and regulatory risk assessment, leveraging strong analytics and client-facing...SeniorRegulatory
$85k - $100k
...will assess, develop, and implement personalized care strategies to foster the emotional well-being and enhanced quality of life for seniors. About the Organization\n Riverbend Psychotherapy Services is a leading mental health provider based in Lowell, Massachusetts....SeniorFull timeRemote workRelocation package- Baker Tilly US, LLP is seeking an IT Audit, Cybersecurity & Risk Senior Consultant (SOC focus) to help client organizations assess... ...while developing subject matter expertise across IT governance, cybersecurity, and regulatory compliance. #J-18808-Ljbffr Baker Tilly USSeniorRegulatory
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