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Form of workPOSITION TITLE: Compliance Specialist
DURATION: 6 Months (possible extension to 9 Months)
Location: Marietta PA
100% ON SITE
Pay Range: $42.22/hr on W2 to $42.22/hr on W2
EDUCATION:
Minimum Level of Job-Related Experience:
Other Job-Related Skills/ Background:
DURATION: 6 Months (possible extension to 9 Months)
Location: Marietta PA
100% ON SITE
Pay Range: $42.22/hr on W2 to $42.22/hr on W2
- 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 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, standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
EDUCATION:
- B.S or B.A in a technical discipline (Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy, Engineering).
- Degree in other 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 on applying RCA for deviations investigations.
- Proficient on 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 clearly 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 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.
