Principal Quality Systems Specialist
4 weeks ago
Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in continual improvement initiatives.
Essential Duties and Responsibilities : include, but are not limited to, the following:
Responsible for ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
Responsible for QA review and approval of the following types of documents:
- Failure investigations
- Corrective and preventative actions (CAPA)
- Standard operating procedures (SOP’s)
- GxP documents
- Change control documents
Reviews various system records for assignment, compliance, and closure.
Provides administrative support of electronic systems
Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
Provision of monitoring and trending metrics associated with site quality systems.
Actively participate in continuous improvement ideas, initiation, and implementation.
Participation in internal, regulatory and customer audits.
May train personnel on quality system processes.
May supervise team members.
Perform additional duties as requested.
Education and Experience:
Principal Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 8 years of industry/relevant experience or equivalent combination of education and experience.
Senior Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 5 years of industry/relevant experience or equivalent combination of education and experience.
Knowledge, Skills, and Abilities:
Ability to develop relationships and coach business users on QMS system requirements.
Excellent written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
Excellent time management, communication, and organizational skills along with a proven ability to multi-task required.
Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
Exhibits a drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail.
Project management skills with the ability to manage many diverse tasks simultaneously.
Effectively organizes and manages work responsibilities under general guidance.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
#JOBSIEPR #IRELIM #REGNIEQA #LI-Onsite
-
Secretary to School Principal
6 days ago
Tarrytown, United States Southern Westchester Boces Full time**PRIMARY PERFORMANCE RESPONSIBILITIES**: - Performs executive secretarial functions for school principal. - Relieves school principals of details which do not require their personal attention by the use of discretion, tact and thorough knowledge of district/office policies and procedures. - Maintains calendar of appointments for the principal, ensuring the...
-
Senior Principal Scientist, Imaging Informatics
4 weeks ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeAs a Senior Principal Scientist – Imaging Informatics you will support the evolving imaging informatics and analysis needs of Regeneron Clinical Imaging. This will include the generate, ingest, standardize, manage, mine, interpret and visualize clinical imaging data effectively to support data-driven decision-making. The position involves collaboration...
-
Desktop Support Specialist
3 days ago
Tarrytown, United States Family Services of Westchester Full timeFamily Services of Westchester (FSW) provides mental health and social services that strengthen and support families, children and individuals at every stage of their lives. With 50 innovative programs, FSW serves 30,000 individuals annually in Westchester County, New York. Founded in 1954, Family Services of Westchester is a private, nonprofit,...
-
Guest Experience Specialist
1 week ago
Tarrytown, United States Marriott Full timeJob Number 24062259 Job Category Rooms & Guest Services Operations Location Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Our jobs aren’t just about giving guests a smooth check-in and check-out....
-
Guest Experience Specialist
6 days ago
Tarrytown, United States Marriott International Full timeJob Number 24062259 Job Category Rooms & Guest Services Operations Location Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Our jobs aren't just about giving guests a smooth check-in and...
-
Guest Experience Specialist
4 weeks ago
Tarrytown, United States Courtyard Tarrytown Greenburgh Full timeJob Number 24062259Job Category Rooms & Guest Services OperationsLocation Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Non-ManagementPosition SummaryOur jobs aren’t just about giving guests a smooth check-in and check-out....
-
Guest Experience Specialist
3 weeks ago
Tarrytown, New York, United States Courtyard Tarrytown Greenburgh Full timeJob Number Job Category Rooms & Guest Services OperationsLocation Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Non-ManagementPosition SummaryOur jobs aren't just about giving guests a smooth check-in and check-out. Instead, we want...
-
Guest Experience Specialist
1 week ago
Tarrytown, United States Marriott International Inc Full timeJob Number 24062259 Job Category Rooms & Guest Services Operations Location Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Our jobs aren’t just about giving guests a smooth check-in and...
-
Guest Experience Specialist
3 weeks ago
Tarrytown, United States Marriott International Inc Full timeJob Number 24062259 Job Category Rooms & Guest Services Operations Location Courtyard Tarrytown Westchester County, 475 White Plains Road, Tarrytown, New York, United States VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Non-Management POSITION SUMMARY Our jobs arent just about giving guests a smooth check-in and check-out....
-
Technical support specialist
7 days ago
Tarrytown, United States TekWissen LLC Full timeJob DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our clients who is a global information technology company that provides high performance and industry focused solutions integrated with leading edge security to clients...
-
Computer Support Specialist
7 days ago
Tarrytown, United States TekwissenGroup Full timeAs a Field Engineer 3, you will perform activities associated with installing, diagnosing, maintaining and servicing computer-related products, including but not limited to desktop & laptop computers, printers, network devices, standard software, and low-end servers at customer sites, and/or depot locations. - This is a journeyman position for the typical...
-
Regulatory Clinical Trials Veeva Consultant
2 weeks ago
Tarrytown, United States Abode Techzone LLC Full timeRegulatory Clinical Trials Veeva Consultant Onsite at Tarrytown, NY 10591 Full Time OR 12 Months Contract It's a Banking Client. Main Skills: Veeva vault platform Gxp and non Gxp Key responsibilities: Experience working with Regulatory and Quality area in Clinical trials. Experience in...
-
Tarrytown, United States GForce Life Sciences Full timeSummary Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Technical Director of Construction. This position will report to an Associate Director of Facilities Project Management or higher, the TTCX Technical Director (TD) shall oversee quality control reviews of all drawings and specifications provided by...
-
Tarrytown, United States GForce Life Sciences Full timeSummary Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Technical Director of Construction. This position will report to an Associate Director of Facilities Project Management or higher, the TTCX Technical Director (TD) shall oversee quality control reviews of all drawings and specifications provided by...
-
Technical Director
4 weeks ago
Tarrytown, United States GForce Life Sciences Full timeSummary Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Technical Director of Construction. This position will report to an Associate Director of Facilities Project Management or higher, the TTCX Technical Director (TD) shall oversee quality control reviews of all drawings and specifications provided by...
-
healthcare Performance Engineer bis
2 weeks ago
Tarrytown, United States Montefiore Full timeHealthcare Performance Engineer. Tarrytown. NY. Provide operational analysis to improve productivity, revenue, efficiency & quality of service to patients. Redesign system. MS in Industrial Engineering or Industrial & Systems Engineering. Annual Salary $100,506.00. Mail CV: Montefiore Medical Center, 3411 Wayne Ave., Bronx, NY 10467, Attn: Leticia Roldan,...
-
Field Engineer 3
4 days ago
Tarrytown, United States Tekwissen Full timeOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our clients who is a global information technology company that provides high performance and industry focused solutions integrated with leading edge security to clients in government, financial...
-
Senior IT Applications Analyst
4 weeks ago
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeAs a Senior IT Applications Analyst (MES) you will be in a business facing role responsible for the configuration, implementation, maintenance, and ongoing support of our MES (Manufacturing Execution Systems) areas. A typical day might include, but is not limited to, the following: Coordinating across business departments and stakeholders, gathering and...
-
Licensed Mental Health Counselor
3 weeks ago
Tarrytown, United States LifeStance Health Full timeIs this you?Wanting to deliver high quality behavioral healthcare.Seeking work life balance.Interested in growing professionally.Outpatient hybrid system.What we offer Therapists:Flexible work schedules with a hybrid system. In person and remote.Full benefits package: health, dental, vision, life, 401k (with match), paid parental leave, and more. Collegial...
-
Electronics Technician
3 weeks ago
Tarrytown, United States Aerolase Full timeJob DescriptionJob DescriptionAbout the company:Join a global leader in miniaturizing high power medical lasers. Our competitors use water cooling and 100+ pound systems to achieve what we can do in a 24 lb air cooled system. Our lasers treat psoriasis, chronic wounds, acne, and the full range of aesthetic applications, Aerolase in Tarrytown, NY has a...