QA Compliance Lead
1 week ago
IRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity. Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success. Job Description - Participating in the development and maintenance of quality systems, processes, and procedures to assure product quality and safety. - Assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities. - Supporting risk management process throughout the product life cycle and providing senior management with key data from RA to help drive decisions. - Supporting development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies. - Assisting in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. - Communicating and implementing a strategy to ensure compliance. - Responsible for review of batch records in support of disposition of bulk drug substance. - Responsible for review of equipment validation protocols and reports. - General compliance quality systems management support for the following areas: - Raw material and solution release. - Review of raw material specifications and solution documents. - Release of single-use disposable product to include label reconciliation. - Review of temperature charts and documents or temperature-related excursions. - Review and update label issuance and reconciliation process. General QA documentation support to include the following: - Issuance of batch records and issuance and tracking of log books, lab notebooks, and SOP binders. - Scanning and filing of excursion documents and client-related batch documents to support batch release. - Developing process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc. Qualifications - BA degree or a minimum of 5 years work experience. - 3 years experience working in a regulated industry. - Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211. - Demonstrated experience and proficiency with MS Office, word processing, spreadsheet (Excel), presentation, and database applications. #J-18808-Ljbffr
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QA Compliance Lead
2 days ago
Marlborough, MA, United States Integrated Resources Inc. Full timeIRI believes in commitment, integrity, and strategic workforce solutions.Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key...
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QA Test Designer
6 days ago
Marlborough, United States Talent Groups Full timePosition Summary:Designs testing as part of various projects for the IS Project Management Office in collaboration with UMMH clinical, operational, vendor, and IS stakeholders.Develops quality assurance tools, activities, and reporting that support the quality goals of IS teams, outside of projects, and collaborates with those groups to incorporate those...
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Supplier QA Associate Director
2 days ago
Marlborough, MA, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Supplier QA Associate Director About the role: The Endoscopy and Urology Associate Director of Supplier Quality Engineering External Operations (Sourced Finished Medical Devices) leads a team of Supplier Quality Engineering Managers to assure supplier and product quality for external manufactured devices. This position...
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Marlborough, Massachusetts, United States MyHR Rescue Full timeAbout the RoleThe EHS Compliance Specialist will lead site environmental compliance, environmental improvement programs, and be a key member of the Site Environmental, Health, and Safety (EH&S) Team. This position is located in Marlborough, MA, and is a manufacturing and research site that is part of the Semiconductor Technologies business with the...
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Supplier QA Associate Director
3 days ago
Marlborough, MA, United States Boston Scientific Gruppe Full timeThe Endoscopy and Urology Associate Director of Supplier Quality Engineering External Operations (Sourced Finished Medical Devices) leads a team of Supplier Quality Engineering Managers to assure supplier and product quality for external manufactured devices. This position offers the successful candidate the opportunity to be an enabler for revenue growth...
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Regulatory Compliance Manufacturing Engineer
1 week ago
Marlborough, Massachusetts, United States Pyramid Consulting Full timeJob DescriptionWe are seeking a highly skilled Regulatory Compliance Manufacturing Engineer to join our team in Marlborough, MA.Company OverviewOur client is a leading Biopharmaceutical Industry with a strong focus on innovation and quality.SalaryThe estimated salary for this position is $65 - $67/hour, plus employee benefits including health insurance,...
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Lead Officer
4 weeks ago
Marlborough, United States Securitas Inc. Full timeSecuritas Security Services is seeking a full-time Lead Officer to work at a client site located in Marlborough, MA Applicants must have strong background in both management and security, with great interpersonal, computer, and customer service skills. * Actively seeking candidates with prior military/law enforcement background Role Description: The Lead...
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Marlborough, United States Digital Federal Credit Union DCU Full timeScheduleExperience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.Monday - Friday 8-5 (40 hours)What You’ll DoSummary/Objective:The Sr. Compliance Officer is responsible for working as a senior member of the Compliance Department to ensure Management’s awareness of, and the credit union’s...
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Construction Management Lead
4 days ago
Marlborough, Massachusetts, United States Michael Page Full timeJob SummaryWe are seeking a highly skilled Construction Superintendent to oversee staff in the field and ensure that construction activities are carried out according to plans, specifications, and quality standards.About the RoleThis is an excellent opportunity for a seasoned professional to lead field staff and create detailed construction schedules,...
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Lead Clinical Therapist
1 week ago
Marlborough, Massachusetts, United States Advocates Full timeOverviewAt Advocates, we are committed to fostering a culture of inclusivity and respect. As a Lead Clinical Therapist, you will play a pivotal role in developing the skills of residential staff and providing therapeutic services to residents requiring additional support.CompensationThe Starting Rate for this position is $71,000, offering a competitive...
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Engineer - Validation
3 weeks ago
marlborough, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: The Validation Engineer (Mid-Level) will be responsible for leading the verification. validation efforts on various industrial automation projects (Plant Pax) will create reports, and ensure that all requirements have been verified. - Approve test cases and protocols using Azure DevOps. - Create verification and validation reports,...
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Engineer - Validation
1 day ago
Marlborough, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: The Validation Engineer (Mid-Level) will be responsible for leading the verification. validation efforts on various industrial automation projects (Plant Pax) will create reports, and ensure that all requirements have been verified. - Approve test cases and protocols using Azure DevOps. - Create verification and validation reports,...
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Lead Technical Accounting Specialist
4 days ago
Marlborough, Massachusetts, United States IPG Photonics Full timeIPG Photonics is a leading manufacturer of high-power laser systems and fiber optics. The company is seeking an experienced and detail-oriented Senior Technical Accountant to support its Corporate Finance team in enhancing financial reporting processes.About the RoleThis role offers the opportunity to work in a dynamic, collegial environment with ample...
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Senior Electrical Engineer
1 week ago
Marlborough, Massachusetts, United States Boston Scientific Full timeElectrical Systems Development Manager for Medical Devices at Boston ScientificAbout the Role:We are seeking an experienced Electrical Systems Development Manager to join our R&D Endoscopy division at Boston Scientific. As a key member of our Systems Engineering & DICE team, you will be responsible for directing and managing the development of complex...
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Marlborough, Massachusetts, United States Entegee Full timeJob OverviewEntegee is a leading provider of custom automation solutions, and we are seeking an experienced Lead Controls Engineer to join our team. The successful candidate will be responsible for managing technical teams through the development of space systems for challenging environments.Salary Details$40.00 to $60.00 per hourKey Responsibilities- Lead...
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marlborough, United States Metrowest Medical Center Full timeProcesses and tests all types of laboratory specimens, reviews and reports lab results, performs operational duties, maintenance, and advanced troubleshooting of laboratory instrumentation and equipment. Acts as resource to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee...
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Automation Test Engineer
4 weeks ago
Marlborough, United States Wipro Full timeAbout Wipro : Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs. We leverage our holistic portfolio of capabilities in consulting, design, engineering, operations, and emerging technologies to help...
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Test Automation Specialist
2 weeks ago
Marlborough, United States Wipro Full timeAbout Wipro :Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs.We leverage our holistic portfolio of capabilities in consulting, design, engineering, operations, and emerging technologies to help...
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Marlborough, United States Metrowest Medical Center Full timeProcesses and tests all types of laboratory specimens, reviews and reports lab results, performs operational duties, maintenance, and advanced troubleshooting of laboratory instrumentation and equipment. Acts as resource to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee...
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Marlborough, United States Metrowest Medical Center Full timeProcesses and tests all types of laboratory specimens, reviews and reports lab results, performs operational duties, maintenance, and advanced troubleshooting of laboratory instrumentation and equipment. Acts as resource to other laboratory personnel. Additional responsibility includes assisting with new equipment validation and implementation, employee...
