Senior Compliance Specialist
4 weeks ago
Sr. Associate Compliance (Product Quality) Fulltime Onsite
We can Relocate
Job Duties:
The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to Product Quality Complaints
- Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
- Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
- Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
- Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
- Manage electronic Quality Management System (TrackWise)
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
- Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
- Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
- Author/revise standard operating procedures (SOPs) and test methods, as required
Other duties as assigned
Education and Experience:
- BS in chemistry or related scientific field
- Superior internal and external customer service/people skills
- Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
Working knowledge of cGMPs, GLPs
Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
Strong knowledge of instrumental and wet analytical chemistry
Strong knowledge of microbiology testing
Strong working knowledge of MS Office software
Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc...
Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
Strong familiarity with
-
Senior Compliance Specialist
4 weeks ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
1 month ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Senior Compliance Specialist
4 weeks ago
Billerica, United States Kaztronix LLC Full timeSr. Associate Compliance (Product Quality) Fulltime Onsite We can RelocateJob Duties: The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and...
-
Quality Assurance Compliance Manager
1 month ago
Billerica, United States Wimmer Solutions Full timeSENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY)BILLERICA, MA (ONSITE)At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their strategic initiatives. We have fun; we love our work. We are positive, kind, and hungry...
-
Senior Manager
7 days ago
Billerica, United States Entegris Full timeJob Title: Senior Manager - SEC Reporting Job Description: Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. The Role: We are seeking a Senior Manager of SEC Reporting to join our team. Responsible for supporting the preparation of SEC...
-
Senior Optical Manufacturing Engineer
1 month ago
Billerica, United States OmniGuide Inc Full timeSenior Optical Manufacturing Engineer OmniGuide Inc. is currently in search of a Senior Optical Manufacturing Engineer specializing in Laser Medical Equipment (Co2 and Thulium Lasers) to join our expanding global Service and Operations team in Billerica, MA. About Us: Located in Billerica, MA, USA, OmniGuide Holdings is a prominent medical device...
-
Senior Optical Manufacturing Engineer
1 week ago
Billerica, United States OmniGuide Full timeSenior Optical Manufacturing Engineer OmniGuide Inc. is currently in search of a Senior Optical Manufacturing Engineer specializing in Laser Medical Equipment (Co2 and Thulium Lasers) to join our expanding global Service and Operations team in Billerica, MA. About Us: Located in Billerica, MA, USA, OmniGuide Holdings is a prominent medical device...
-
Sr Manufacturing Engineer
2 weeks ago
Billerica, United States LanceSoft Full timeNice to Have: Catheter Process Improvement quality system remidiation JOB DESCRIPTION Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant...
-
Web Access Specialist
4 weeks ago
Billerica, United States Connexion Systems + Engineering Full timeConnexions mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.Title: Web Access Specialist Hiring Organization: Connexion Systems & EngineeringCompensation, Benefits, and Employment...
-
Employee Relations Specialist
7 days ago
Billerica, United States PAREXEL Full timeIn this role as an Employee Relations Specialist, you will develop and implement independent human resources solutions in support of business objectives, strategic goals, and human resource initiatives for the designated business unit. Additionally, you will perform duties associated with human resources areas such as employee onboarding, employee relations,...
-
Sr Manufacturing Engineer
2 weeks ago
Billerica, United States LanceSoft Full timeNice to Have: Catheter Process Improvement quality system remidiation JOB DESCRIPTION Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant...
-
Senior Technical Supervisor
1 week ago
Billerica, United States Medtronic Inc. Full timeCareers that Change Lives We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be....
-
Senior/Staff Electrolyte Scientist
1 month ago
Billerica, United States Factorial Energy Full timeJob DescriptionJob DescriptionEmpowering a Sustainable FutureFactorial Energy is a dynamic venture-backed company dedicated to creating a sustainable future. With a passionate team of engineers and business professionals, Factorial is developing breakthrough solid-state battery technology to enable safe, scalable, and high-performance cells for electric...
-
Senior Optical Manufacturing Engineer
1 month ago
Billerica, MA, United States OmniGuide Inc Full timeSenior Optical Manufacturing Engineer OmniGuide Inc. is currently in search of a Senior Optical Manufacturing Engineer specializing in Laser Medical Equipment (Co2 and Thulium Lasers) to join our expanding global Service and Operations team in Billerica, MA. Located in Billerica, MA, USA, OmniGuide Holdings is a prominent medical device manufacturer...
-
Senior Optical Manufacturing Engineer
1 month ago
Billerica, MA, United States OmniGuide Inc Full timeSenior Optical Manufacturing Engineer OmniGuide Inc. is currently in search of a Senior Optical Manufacturing Engineer specializing in Laser Medical Equipment (Co2 and Thulium Lasers) to join our expanding global Service and Operations team in Billerica, MA. About Us: Located in Billerica, MA, USA, OmniGuide Holdings is a prominent medical device...
-
Homecare Scheduler
1 week ago
Billerica, United States Guardian Angel Senior Services Full timeJob DescriptionJob Descriptionour missionIs to provide home care service with love; to enhance the quality of living through our attentive yet subtle style of care; to maintain their dignity and their independence while serving their needs with honor and integrity. After all, it is their home!Basic FunctionTo support caregiver and company needs. Process...
-
Homecare Scheduler
4 days ago
Billerica, United States Guardian Angel Senior Services Full timeJob DescriptionJob Descriptionour missionIs to provide home care service with love; to enhance the quality of living through our attentive yet subtle style of care; to maintain their dignity and their independence while serving their needs with honor and integrity. After all, it is their home!Basic FunctionTo support caregiver and company needs. Process...
-
Homecare Scheduler
2 days ago
Billerica, United States Guardian Angel Senior Services Full timeJob DescriptionJob Descriptionour missionIs to provide home care service with love; to enhance the quality of living through our attentive yet subtle style of care; to maintain their dignity and their independence while serving their needs with honor and integrity. After all, it is their home!Basic FunctionTo support caregiver and company needs. Process...
-
Homecare Scheduler
2 days ago
Billerica, United States Guardian Angel Senior Services Full timeJob DescriptionJob Descriptionour missionIs to provide home care service with love; to enhance the quality of living through our attentive yet subtle style of care; to maintain their dignity and their independence while serving their needs with honor and integrity. After all, it is their home!Basic FunctionTo support caregiver and company needs. Process...
-
Accounting Manager
4 weeks ago
Billerica, United States ASM Pacific Technology Full timeAs an Accounting Manager for ASM NEXX, Inc., you will work alongside the Senior Team to drive the strategy and success of our business. A successful leader in this role will develop and lead the accounting team, be a strong cross-functional collaborator, an exceptional communicator, and strategic thinker. The ideal candidate will serve as a thought leader...