Total Quality Senior Specialist jobs in Pennsylvania
Total Quality Senior Specialist contributes to the development, implementation, administration and measurement of total quality management programs, including Six Sigma initiatives. Provides expertise to cross functional teams to facilitate total quality methods, training, tool development, and logistical support. Being a Total Quality Senior Specialist coordinates with production, operations, customer service and other functions to implement programs. Typically requires a bachelor's degree. Additionally, Total Quality Senior Specialist typically reports to a manager. The Total Quality Senior Specialist work is highly independent. May assume a team lead role for the work group. A specialist on complex technical and business matters. To be a Total Quality Senior Specialist typically requires 7+ years of related experience. (Copyright 2024 Salary.com)
Recently Added Total Quality Senior Specialist jobs
Senior Quality Compliance Specialist
- Integrated Resources INC
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Wayne, PA
FULL_TIME
- Company DescriptionA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionPosition Details:Client: Direct ClientJob Title: Quality Compliance Specialist IIILocation: Wayne, PADuration: 7 Months (Possible Extension)Job Summary:The Product Surveillance Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and to deliver appropriate support in-line products enable a sustainable existence on the market. Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint handling, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions in to the post marketing surveillance. Post Marketing Product Quality Surveillance: • Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to• Effective global Product Quality Compliant Handling • Effective global Product Annual / Periodic Product Quality Review • Effective global Product Recall Management • Support the provision of metrics regarding key performance indicators of quality from Product• Quality Surveillance System in support of Suppliers • Active participation in team meetings, demonstrated ability to interact professionally and effectively with peers, management, and leadership both within and outside the department, within and outside the company, including regulatory agencies and business partners on a global basis. • Must possess ability to work in a goal-oriented, time line driven, and dynamic work environment. • Must be a well organized, self-motivated, and demonstrate an independent work style with the ability to initiate and follow through on goals and project schedules. Specifically the Complaint Specialist shall: • Process global commercial / clinical product Quality Complaints received • Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations • Liaise with International Quality to ensure intake of appropriately redacted international complaint data is received assessed and processed and potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately • Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions • Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management • Communicate adverse events reported in conjunction with PQCs to PVRM • Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor)for inspection / investigation • Coordinate pharmacy credits for returned product through Customer service • Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and site investigations in conjunction with Quality Assurance • Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriate • Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international QA to ensure local communication requirements are met. • Generate reports for management and inspections as required • Assist as needed in the preparation of data for internal audits and external audits / inspections• Participate in third party call monitoring to ensure correct communication strategies are being utilized. Transition/ Integration support: • The candidate will additionally supported the transition and integration of legacy Product Quality Management quality systems for Complaints, Incident Management, APQR and Recall in to one solutions. • Transition the ownership and processing of Complaints into PQM – execute a compliant transition, manage the SOP updates • Support One Complaint system integration (One workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements) Support as needed: • One APQR system integration and enhacements (workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements). Support in the delivery of the new Canadian YBPR requirements • Support the PQM Product Quality System alignment into single One Quality System • Support change management of introduction of acquisition / integration / new products into and divestment of products out of the PQM Product Quality Systems • Integration of One Recall and Withdrawal processes • Integration of One Board of Health Notification processes QualificationsEducation and Experience Requirements • MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing• Previous experience investigating and processing Product Quality Complaints required. • The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations. • Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.• TrackWise experience preferred. Internal and External Contacts • Internal contacts: PQM Leads, International Quality, North America Quality Assurance, Regulatory Compliance, Pharmaceutical Sciences, Global Pharmaceutical Technology, Global Regulatory Affairs.• External contacts: Contract OrganizationsFeel free to forward my email to your friends/colleagues who might be availableAdditional InformationThanks!!!Warm Regards,Amrit SinghClinical RecruiterIntegrated Resources, Inc.IT REHAB CLINICAL NURSINGTel: (732) 429 1634 (Direct)Ext: (732) 549 2030 x (212) Fax: (732) 549 5549http://www.irionline.comInc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012, 2013 & 2014 (8th Year)Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70https://www.linkedin.com/company/46970?trk=prof-exp-company-name
- 1 Month Ago
Senior Quality Specialist
- Eurofins
-
Lancaster, PA
FULL_TIME
- Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our en...
- 1 Month Ago
Senior Quality Assurance Specialist
- Eurofins
-
Lancaster, PA
FULL_TIME
- Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our en...
- 1 Month Ago
Senior Quality Release Specialist
- Iovance Biotherapeutics Inc
-
Philadelphia, PA
FULL_TIME
- Overview The Quality Release Specialist will support review of documentation and support releasing of materials and products. Specific Responsibilities Ensure compliance to cGMPs and facility procedur...
- 2 Months Ago
Senior QA Specialist - Supplier Quality
- System One
-
Philadelphia, PA
OTHER
- Title: Senior QA Specialist - Supplier Quality Location: Onsite, Philadelphia, PA 19112 Schedule: M-F 8am-5pm Type: Direct/Permanent Compensation: Competitive salary with an excellent benefits package...
- 2 Months Ago
Senior Specialist, Quality Assurance Compliance (Hybrid)
- Iovance Biotherapeutics Inc
-
Philadelphia, PA
FULL_TIME
- We are hiring ! We are hosting an onsite Job Fair at : Iovance Cell Therapy Center (iCTC) Thursday, March 21 12pm to 6pm (ET) 300 Rouse Blvd Philadelphia, PA 19112 See you at the Job Fair Overview Iov...
- 11 Days Ago
Total Quality Senior Specialist jobs at Popular Companies
Assistant Quality Manager
- Hiring Now!
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Hammond, IN
- Our client is currently seeking an Assistant Quality ManagerHammond IN FIRST SHIFT Direct Hire Salary range $100,000 to ...
- 4/13/2024 12:00:00 AM
Quality Specialist
- Flatiron Construction Corp
-
Concord, CA
- Come join our NorCal team (Bay Area/Sacramento) as a Quality Specialist! A great opportunity to join an industry-leading...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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York, PA
- Our client is currently seeking an Assistant Quality Manager in Virginia.This job will have the following responsibiliti...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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Hershey, PA
- Our client is currently seeking an Assistant Quality Manager in Virginia.This job will have the following responsibiliti...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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Norfolk, VA
- Our client is currently seeking an Assistant Quality Manager in Virginia. This job will have the following responsibilit...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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Richmond, VA
- Our client is currently seeking an Assistant Quality Manager in Virginia.This job will have the following responsibiliti...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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Martinsburg, WV
- Our client is currently seeking an Assistant Quality Manager in Virginia.This job will have the following responsibiliti...
- 4/12/2024 12:00:00 AM
Assistant Quality Manager
- Hiring Now!
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Newport News, VA
- Our client is currently seeking an Assistant Quality Manager in Virginia.This job will have the following responsibiliti...
- 4/12/2024 12:00:00 AM
About Pennsylvania
Pennsylvania (/ˌpɛnsɪlˈveɪniə/ (listen) PEN-sil-VAY-nee-ə), officially the Commonwealth of Pennsylvania, is a state located in the northeastern and Mid-Atlantic regions of the United States. The Appalachian Mountains run through its middle. The Commonwealth is bordered by Delaware to the southeast, Maryland to the south, West Virginia to the southwest, Ohio to the west, Lake Erie and the Canadian province of Ontario to the northwest, New York to the north, and New Jersey to the east.
Pennsylvania is the 33rd-largest state by area, and the 6th-most populous state according to the most recent of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Senior Specialist jobs
$112,556 to $133,937
Most Popular Cities in Pennsylvania for Total Quality Senior Specialist Jobs
What does a Total Quality Senior Specialist do?
Total Quality Senior Specialist in Columbia, SC
Likely to be either a specialist within a particular focus area for QHSE, e.g., environmental, transportation, training, etc., or is based at a specific location in a generalized role.
February 18, 2020