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Quality Assurance Compliance Specialist

1 month ago

New York, United States EPM Scientific Full time

Job Summary

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 analyses trends to implement corrective and preventive actions to mitigate adverse trends.


Area Of Responsibility

  • 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 Job Qualification

  • B.S. 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


Experience

  • 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 regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture