Compliance Specialist II
3 weeks ago
Job Description
This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis, and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right-first-time performance. The Compliance Specialist supports by working cross-functionally with internal support departments to drive improvements to completion.
Job Responsibilities
- Lead event investigations to adequately identify root causes and implement appropriate corrective and preventative actions to prevent reoccurrence,
- Lead CAPA investigations and at times manage the implementation of CAPA.
- Own manufacturing-related change controls.
- Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
- Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
- Review production documentation and perform quality walk-throughs during manufacturing events
- Participate in continuous improvement teams such as 5s, Gemba, and Production Systems (GPS).
- Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
- Lead team meetings and facilitate multidepartment discussions.
- Stay current with biopharmaceutical industry best practices and technologies.
- Other duties as assigned
Education & Qualifications
- Bachelor's degree or equivalent experience.
- 3+ years of related experience.
- Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single-use technology (SUT).
- Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
- Good computer skills, and knowledge of Microsoft Office products – Word, Excel, Office.
- Collaborate with cross-functional teams to integrate compliance measures into various aspects of manufacturing operations.
- Ability to work in a clean room environment and comply with hygiene standards and use of cleanroom gowning.
Preferred Qualifications:
- If you have the following characteristics, it would be a plus:
- SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single-use technology (SUT), buffer preparation, and filtration.
- Experience with regulatory agency interactions and inspection discussions preferred but not required.
- Excellent verbal/written communication skills.
- Facilitation and demonstration skills
- Attention to detail and the ability to work individually and within multi-disciplinary teams
- More advanced knowledge/proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP)
-
Compliance Specialist II
7 days ago
Cambridge, United States Randstad Life Sciences US Full timeJob Description This exciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis, and the...
-
Labor Relations Specialist
2 weeks ago
Cambridge, United States Massachusetts Institute of Technology Full timeLABOR RELATIONS SPECIALIST Human Resources (HR)-Labor Relations , to assist the manager of labor relations with the administration and interpretation of MIT’s seven collective bargaining agreements. Responsibilities include: Guiding DLC (departments, labs, and centers) managers/supervisors concerning contract compliance and other issues related to...
-
Environmental Health Safety Specialist
1 month ago
Cambridge, United States Randstad Life Sciences US Full timeImmediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...
-
Environmental Health Safety Specialist
4 weeks ago
Cambridge, United States Randstad Life Sciences US Full timeImmediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...
-
Environmental Health Safety Specialist
4 weeks ago
Cambridge, United States Randstad Life Sciences US Full timeImmediate opportunity for an Environmental Health & Safety Specialist II to work with multi-national pharmaceutical company dedicated to pharmaceutical research and vaccine development. The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately...
-
IT Support Specialist
7 days ago
Cambridge, United States Scilligence Full timeReporting Relationship: This position will report to the IT Manager Job Description: We are looking for an IT Support Specialist to join our Cambridge team in Massachusetts. The primary role of this position will be to support our developed applications when it applies to information technology systems. * Deploy and configure Scilligence solutions for...
-
Environmental Health and Safety Specialist II
3 weeks ago
Cambridge, United States The Fountain Group Full timeOnsite role in Cambridge, MA W2 Candidates onlyManager Updates/Required Skills Must have Safety related experience within Research and Development or Pharma Employers Bachelor's degree Min of 3+ years of experience - direct safety-related experience Senior HSE level experience required Self-driven, ability to take on projects Preferred / Nice to Have...
-
Scientist I/II
1 month ago
Cambridge, Massachusetts, United States UCB Full timeMake your mark for patients We are currently seeking a highly skilled and motivated Scientist I/II with expertise in molecular and cellular biology to join our Discovery Biology team. The candidate will be expected to design, execute and analyze in vivo experiments to validate gene therapy targets for the treatment of genetic diseases. This is a unique...
-
Principal Scientist Ii, Drug Discovery
23 hours ago
Cambridge, United States Novartis Full time**Summary**: Internal Job Title: Principal Scientist II Job Location: Cambridge, MA onsite About the role: We are seeking an innovative and dynamic scientist with broad expertise in nephrology to join a vibrant research team focused on finding new transformative therapies for people living with renal disease. In this role, you will be responsible for driving...
-
Biopharma Quality Systems Specialist
1 day ago
Cambridge, United States Experis Full timeOur client, a well know pharma company is seeking a Quality Systems Specialist to join their team. As a Quality Systems Specialist, on this 6 month contract you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations....
-
Laboratory Specialist
1 week ago
Cambridge, United States Planet Pharma Full timeThis position will report to an onsite facility full-time in Cambridge, MA.Job Description Summary:We are looking for a highly motivated Instrument Support Specialist to provide critical, on-site, scientific and operational support as part of a dynamic lab service team. The role is mainly responsible for supporting Flow Cytometry and FACS equipment and...
-
Laboratory Specialist
5 days ago
Cambridge, United States Planet Pharma Full timeThis position will report to an onsite facility full-time in Cambridge, MA.Job Description Summary:We are looking for a highly motivated Instrument Support Specialist to provide critical, on-site, scientific and operational support as part of a dynamic lab service team. The role is mainly responsible for supporting Flow Cytometry and FACS equipment and...
-
Contract - Quality Assurance Specialist, Cmc
4 days ago
Cambridge, United States Vedanta Biosciences Full time**Title: Contract - Quality Assurance Specialist, CMC** **Location: Cambridge, MA and Acton, MA** **Reports to: Supervisor, Quality Assurance** **About Vedanta Biosciences**: **The Role**: The QA CMC Specialist is responsible for performing a wide variety of activities to ensure manufacturing compliance with applicable regulatory and CGMP requirements....
-
Implementation and Operations Specialist
1 month ago
Cambridge, Massachusetts, United States Quality Coding Software Solutions LLC Full timeImplementation and Operations SpecialistJob DescriptionOverviewQuality Coding Software Solutions is seeking an Implementation and Operations Specialist to support our Managed Care and Community based healthcare clients. We offer an exciting opportunity to support health care insurers and providers in improving health care outcomes for vulnerable populations....
-
Cambridge, United States Peak Support LLC Full timeJob DescriptionJob DescriptionDescription:Join Peak Support: Where Passion Meets PurposeAt Peak Support, we're not just another outsourcing company—we're a dynamic, fast-growing team that values integrity, respect, excellence, collaboration, and compassion. As a Great Place to Work-Certified™ company with the best Glassdoor rating in the business...
-
Cambridge, Massachusetts, United States Vedanta Biosciences Full timeTitle: Contract - Quality Assurance Specialist, CMCLocation: Cambridge, MA and Acton, MA Reports to: Supervisor, Quality AssuranceAbout Vedanta Biosciences:Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include potential first-in-class oral...
-
Senior Specialist, Site Quality Systems
3 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Mammographer II
2 weeks ago
Cambridge, United States University of Maryland Medical System Full timeJob DescriptionCompany DescriptionAt Shore Regional Health, you can learn, grow and make a lasting impact on patients and families. You’ll experience the support of a collaborative work environment and a sense of collegiality unlike any other. Our comprehensive system has many locations and practice options to choose from throughout the beautiful Eastern...
-
Mammographer II
3 weeks ago
Cambridge, United States University of Maryland Medical System Full timeJob DescriptionCompany DescriptionAt Shore Regional Health, you can learn, grow and make a lasting impact on patients and families. You’ll experience the support of a collaborative work environment and a sense of collegiality unlike any other. Our comprehensive system has many locations and practice options to choose from throughout the beautiful Eastern...
-
Mammographer II
4 weeks ago
Cambridge, United States University of Maryland Medical System Full timeJob DescriptionJob DescriptionCompany DescriptionAt Shore Regional Health, you can learn, grow and make a lasting impact on patients and families. You’ll experience the support of a collaborative work environment and a sense of collegiality unlike any other. Our comprehensive system has many locations and practice options to choose from throughout the...