Compliance Specialist

12/6/22

Bethlehem, PA

1869

#1869 Quality Assurance Compliance Specialist

Essential Duties and Responsibilities

  • Packaging Batch Records: issues batch records to packaging, reviews final batch records, documents batch errors from various departments, tracks, and issues reports
  • Responsible for certificate of acceptance (C of A) generation for finished drug product, coordination of finished batch status tracking and batch release
  • Releases product within SAP and generates reports
  • Production Batch Records: issues batch records to production, review production batch records, file and archive all the completed records.
  • Reviews calibration sheets.
  • Monitors and provides trend analysis of DIs, LIs, CAPAs, customer complaints, and change controls
  • Responsible for the quality document archive system
  • Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases
  • Assist in the activities related to document control when needed
  • Assists in investigations as needed
  • Act as a backup to other Compliance associate in his/her absence
  • Performs and supports internal audits and regulatory agencies audit
  • Supports launch of new products in auditing/ understanding new processes
  • Performs special projects as directed by Quality Assurance management Qualifications

Education/Experience:

  • Minimum of 4-year degree in science or technical field, preferably Chemistry or similar discipline (or combination of equivalent experience) preferred
  • Minimum of 5 years’ experience in a regulated industry; Pharmaceutical or Medical device
  • Knowledge of GMPs, GDPs, GLPs and Quality Assurance/Quality Control skills required
  • Understanding of quality systems and processes
  • Excellent verbal and written communication skills
  • Experience with Microsoft Office applications and Trackwise systems (SAP and EDMS experience a plus)
  • Experience within a manufacturing and/or packaging environment
  • Demonstrated ability for effective communication, teamwork, and problem solving skills
  • Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
  • Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
  • Excellent verbal and written communication skills
  • Creative and able to present various solutions
  • Energetic, enthusiastic and motivational disposition

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