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Senior Quality Compliance Specialist

2 months ago

Butler, Pennsylvania, United States Integrated Resources Full time
{"Job Title": "Senior Quality Compliance Specialist", "Job Summary": "We are seeking a highly skilled Senior Quality Compliance Specialist to join our team at Integrated Resources, Inc. This role will be responsible for delivering Product Quality Surveillance activities and providing support in-line products to ensure a sustainable existence on the market. The ideal candidate will have a strong scientific background, technical expertise, and experience in investigating and processing Product Quality Complaints.

Responsibilities:

* Provide support to delivery, drive, and maintain effective Product Quality Surveillance systems
* Process global commercial/clinical product Quality Complaints received
* Assess incoming Product Quality Complaints (PQC) and escalate potential issues/incidents to management
* Liaise with International Quality to ensure intake of appropriately redacted international complaint data is received, assessed, and processed
* Assign actions related to each PQC investigation and work with Technical and Quality personnel to drive timely delivery of these actions
* Perform trend analysis on all incoming PQCs and escalate to incidents and potential risks to management
* Communicate adverse events reported in conjunction with PQCs to PVRM
* Facilitate complaint sample returns 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
* Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant/local QA
* Generate reports for management and inspections as required
* Assist 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:

* Support the transition and integration of legacy Product Quality Management quality systems for Complaints, Incident Management, APQR, and Recall into one solution
* Transition the ownership and processing of Complaints into PQM and execute a compliant transition
* Support One Complaint system integration (One workflow design, user testing, training, and education, GO Live, and Hyper care/subsequent required enhancements)
* Support One APQR system integration and enhancements (workflow design, user testing, training, and education, GO Live, and Hyper care/subsequent required enhancements)
* 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

Qualifications:

* MS or Bachelor's degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience
* Previous experience investigating and processing Product Quality Complaints required
* Strong scientific background and technical expertise to ensure robust analysis of complex product data
* Ability to assess information to make scientifically sound quality risk-based recommendations
* Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs
* 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 Organizations
"}