Quality Assurance Manager
4 weeks ago
JOB DESCRIPTION – QA Manager, System Compliance
Scope of Function:
Responsible for leading the development, implementation, and maintenance of Quality Systems in support of combination drug products to include, but not limited to: Policies and Procedures, Deviations, CAPA’s, Document and Change Controls, Validation, Internal Auditing, Supplier and Material Management, and Training.
Reports to: Sr. Director, Head of Quality
Specific Duties:
- revise, edit and format Standard Operating Procedures, Logbooks, Specifications, Batch Records and other documentation according to written procedures.
- storage of Master Files and executed documents in accordance with internal procedures.
- Quality Systems Policies to reflect industry best practices. Identify procedural gaps/improvements for transition to commercial testing and manufacturing. Work in tandem with subject matter experts to address gaps.
Facilitate in the investigation of customer complaints and/or internal non-conformances.
- the Quality Systems readiness for regulatory and customer inspections.
- investigate and close Incident reports, Deviations, Investigations, Change Controls and CAPAs.
- QA review and approval all equipment master records, IQ/OQ/PQ, transfer forms, status change forms, calibration and preventive maintenance records.
- QMS routine meetings such as Deviation and change control.
Participate as needed in client audits as well as regulatory audits.
- record and Label generation and reconciliation.
- Room/Equipment Compliance and clearance activities as needed. .
- Annual Updates of DMF to FDA.
Responsible for maintenance of the Supplier Management program.
Reviews all Policies and Procedures for the Division.
Develops, maintains and monitors Metrics for the Quality Department.
Responsible for the adequacy and improvement of the training program.
Ensures that all products are manufactured in compliance with 21 CFR 211 or other applicable regulations.
Education and Experience Required:
Bachelor's degree in Life Sciences or a related scientific field
Minimum of seven years’ experience working in an FDA regulated environment in Biologics, Pharmaceuticals, Medical Devices, or Tissue.
Minimum one year working with Electronic Quality Management Systems such as Master Control, Documentum, Qualio, or Trackwise
Skills:
Proficiency with technical writing and written and verbal communication.
Interacts with:
All TBI employees, clients, consultants, and global regulatory agencies.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
-
Quality Specialist II
3 weeks ago
Weston, United States AMISEQ Full timeMust Haves: • Bachelor’s degree (preferred), associate degree (required). • Must possess intermediate to proficient skillset in Excel when reviewing large data and general Microsoft Applications. • Written and oral communication skills via email and phone when presenting to internal and external stakeholders is a must. • Track record of strong...
-
Quality Specialist II
3 weeks ago
Weston, United States AMISEQ Full timeMust Haves: • Bachelor’s degree (preferred), associate degree (required). • Must possess intermediate to proficient skillset in Excel when reviewing large data and general Microsoft Applications. • Written and oral communication skills via email and phone when presenting to internal and external stakeholders is a must. • Track record of strong...
-
Senior Technical Project Manager
16 hours ago
Weston, United States Postal Center International® | PCI® Full timeJob Summary:Postal Center International (PCI) is seeking a highly skilled and dynamic IT Sr Technical Project Manager to join our team. The successful candidate will be responsible for leading sprint planning, client data integrations, and various IT projects related to security, ERP, Quality and Software Development, this role requires exceptional project...
-
Senior Technical Project Manager
1 week ago
Weston, United States Postal Center International® | PCI® Full timeJob Summary:Postal Center International (PCI) is seeking a highly skilled and dynamic IT Sr Technical Project Manager to join our team. The successful candidate will be responsible for leading sprint planning, client data integrations, and various IT projects related to security, ERP, Quality and Software Development, this role requires exceptional project...
-
Weston, United States Mon Health Full timeStonewall Jackson Memorial Hospital joined Mon Health in October 2017. Our Hospital i s a 70-bed general medical and surgical hospital in Weston, WV. It primarily serves Lewis, Gilmer, Braxton and Upshur counties. We're seeking a dedicated, passionate OBGYN physician to provide high quality care to patients in a beautiful community healthcare setting. The...
-
Secretarial Position
2 weeks ago
Weston, United States Connecticut REAP Full timeJob Description: Weston Public Schools WESTON PUBLIC SCHOOLS Weston, Connecticut JOB DESCRIPTION Administrative Assistant Position Goal: Administrative Assistant - Hurlbutt Elementary School Duties: Performs all general office tasks including accounts receivable, maintenance of personnel records, budget preparation, general correspondence, telephone,...
-
Environmental Health and Safety Manager
3 days ago
Weston, United States Higheredmilitary Full time**Environmental Health and Safety Manager (83705)** Weston, MA **Type:** Full-Time **Posted:** 10/11/2021 **Summary** Within the division of Finance and Business and under the general supervision of the Director of Facilities, the Environmental Health and Safety Manager will implement and execute Regis College's environmental health and safety (EH&S)...
-
Real Estate Transaction Coordinator
3 weeks ago
Weston, United States Keller Williams Realty - Level 5 Leadership Full timeJob DescriptionJob DescriptionWe’re looking for a driven transaction coordinator to manage contracts throughout the entire home selling and buying process. You’d be responsible for overseeing transactions from start to finish to ensure offers and counteroffers are approved for a smooth and successful sale. Our ideal candidate is extremely organized and...
-
RN Case Manager
3 weeks ago
Weston, FL, United States Cleveland Clinic in Florida - Weston Full timeRN Case Manager - Full Time This position works collaboratively with inter-professional teams across the continuum of care to facilitate and ensure effective transitional care coordination. Essential to this role are the core values of patient advocacy, holistic assessment, care planning, and the empowerment of patients and families to self-manage. The...
-
Full Time Cardiac Surgery
4 weeks ago
Weston, United States BAS Healthcare Locums, LLC Full timeLocation: Weston, Wisconsin is a pleasant village located in Marathon County, in the central part of the state. It's part of the Wausau metropolitan area and is known for its friendly community, excellent schools, and proximity to outdoor recreational opportunities. The village has seen steady growth and development, offering a mix of residential...
-
Full Time Cardiac Surgery
4 weeks ago
Weston, United States BAS Healthcare Locums, LLC Full timeLocation: Weston, Wisconsin is a pleasant village located in Marathon County, in the central part of the state. It's part of the Wausau metropolitan area and is known for its friendly community, excellent schools, and proximity to outdoor recreational opportunities. The village has seen steady growth and development, offering a mix of residential...
-
Sr. Collections Associate
7 days ago
Weston, United States SellersFi Full timeJob Summary SellersFi (the “Company”) is hiring a Sr. Collections Associate on a full-time basis, reporting directly to the Global Collections Manager. The candidate filling this role will be responsible for overseeing collections on all delinquent accounts whilst ensuring best efforts to maximize recoveries via account modifications and...
-
Process Improvement Lead I
2 weeks ago
Weston, United States AMISEQ Full timeOverview & Responsibilities:In this role, you will manage projects related to this exciting and trailblazing program and other cross-functional initiatives.Under limited supervision, you will be responsible for establishing, leading, and executing assigned continuous process improvement initiatives, acting as a liaison between operational and technical teams...
-
Process Improvement Lead I
3 weeks ago
Weston, United States AMISEQ Full timeOverview & Responsibilities:In this role, you will manage projects related to this exciting and trailblazing program and other cross-functional initiatives.Under limited supervision, you will be responsible for establishing, leading, and executing assigned continuous process improvement initiatives, acting as a liaison between operational and technical teams...
-
Process Improvement Lead I
3 weeks ago
Weston, United States AMISEQ Full timeOverview & Responsibilities:In this role, you will manage projects related to this exciting and trailblazing program and other cross-functional initiatives.Under limited supervision, you will be responsible for establishing, leading, and executing assigned continuous process improvement initiatives, acting as a liaison between operational and technical teams...
-
Process Improvement Lead
3 weeks ago
Weston, United States Aequor Healthcare Services Full timeDescription:Shift Schedule: Hybrid. Minimum 3 days in office and 2 from home. Monday – Friday 9:00a – 6:00p**This role is temp only.**Candidates must have the following to be considered for the role:• Most recent experience needs to be Process Improvement.• 5 -7 years process improvement experience• Lean Six Sigma Green or Black Belt.- Strong...
-
Process Improvement Lead
3 weeks ago
Weston, United States Aequor Healthcare Services Full timeDescription:Shift Schedule: Hybrid. Minimum 3 days in office and 2 from home. Monday – Friday 9:00a – 6:00p**This role is temp only.**Candidates must have the following to be considered for the role:• Most recent experience needs to be Process Improvement.• 5 -7 years process improvement experience• Lean Six Sigma Green or Black Belt.- Strong...
-
Process Improvement Lead
4 weeks ago
Weston, United States Aequor Healthcare Services Full timeDescription:Shift Schedule: Hybrid. Minimum 3 days in office and 2 from home. Monday – Friday 9:00a – 6:00p**This role is temp only.**Candidates must have the following to be considered for the role:• Most recent experience needs to be Process Improvement.• 5 -7 years process improvement experience• Lean Six Sigma Green or Black Belt.- Strong...
-
Territory Sales Representative
3 days ago
Weston, United States Insight Global Full timeMUST HAVES: 2+ years of B2B sales experienceProven track record hitting KPI's (quota's, calls out, business brought in, etc.)Experience building a book of business from the ground up Plusses:Experience selling leasesExperience within the industry Salesforce Day to day:My client, which is one of the nation’s largest office equipment, solution software...
-
Territory Sales Representative
16 hours ago
Weston, United States Insight Global Full timeMUST HAVES: 2+ years of B2B sales experienceProven track record hitting KPI's (quota's, calls out, business brought in, etc.)Experience building a book of business from the ground up Plusses:Experience selling leasesExperience within the industry Salesforce Day to day:My client, which is one of the nation’s largest office equipment, solution software...