Compliance Specialist

Location: Marietta, PA
Department: Azzur Princeton, LLC

Job Description

We at Azzur Group are looking for a Compliance Specialist to join our Azzur Consulting: Philadelphia division. This position will lead deviation (unplanned events) investigations, identify root cause through root cause analysis (RCA) and determine CAPAs, as well as write deviations.

Key Responsibilities:
  • Lead cross functional team to investigate deviations. Write deviations using a qualified system such as SAP and prepare clear, concise reports from outcome of investigations.
  • Perform root cause analysis.
  • Determine robust corrective actions and / or commitments.
  • Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
  • Review of records to include batch documentation, training records, calibration records, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.
  • Communicate immediately with QA and Operations management for all manufacturing discrepancies that impact product quality or safety.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, & safety procedures, and industry practice and Industrial Excellence initiatives.

Requirements:
  • B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience for the job purpose.
  • Demonstrated problem solving and investigational skills.
  • The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
  • The ability to clearly write technical documentation.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines
  • Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
  • Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
  • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a high complex matrix environment.
  • Able to maintain attention to detail while executing multiple tasks.
  • Able to perform job duties with minimal supervision.
  • Sense of urgency, flexibility and accountability.
  • Intermediate computer skills required.



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