Compliance Specialist II

4 weeks ago

Marietta, United States Randstad Life Sciences Full time
Job DescriptionJob Description

6 Months (Possible extension to 9 Months)

Marietta, PA

100% ON SITE

 

RESPONSIBILITIES

  • This position will perform deviation (unplanned events) investigations, identify root cause through root cause analysis (RCA) and determine CAPAs.
  • Investigate manufacture deviations (unplanned events)
  • Perform root cause analysis, using RCA tools.
  • Determine robust corrective actions and / or commitments.
  • Write deviations in SAP and prepare clear, concise reports from the outcome of investigations.
  • Interact and coordinate with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
  • For RCA, review 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, company standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.

EDUCATION / REQUIREMENTS

EDUCATION:

  • B.S or B.A in a technical discipline (Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy, Engineering).
  • Degree in another discipline if sufficient technical depth has been achieved from professional experience for the job purpose.

Minimum Level of Job-Related Experience:

  • Minimum of 2 years of demonstrated professional experience investigating manufacturing deviations, either in a QA, compliance, or manufacturing role in the pharmaceutical industry or equivalent, preferably in aseptic processes/areas.
  • In-depth knowledge of root cause analysis methodologies, through training and practice.
  • Proficient in applying RCA for deviation investigations.
  • Proficient in deviation writing

Other Job-Related Skills/ Background:

  • 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 write technical documentation.
  • SAP skills are a plus
  • 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 to apply knowledge to daily activities.
  • Knowledge of GMPs, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
  • Able to interact with peers, subordinates and senior personnel in multidisciplinary environments including engineering, facility operations, validation, production and QA. Ability to work in a highly 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.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industryCompany DescriptionA great company doing groundbreaking and important work with a great reputation in the industry

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