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Compliance Specialist

Fort Worth Metro Area, TX

Post Date: 06/28/2018 Job ID: JN -062018-21947 Job Type: Scientific
Description:
Using references and knowledge of relevant guidance/regulatory documents, contractor will perform compliance activities supporting Change Control and Regulatory documentation related to:
  • registration support
  • artwork management
  • specification updates
  • other quality activities as assigned

Impact
  • Ensure compliance to internal procedures and external guidelines
  • Maximize on-time completion of compliance actions
  • Minimize delays leading to manufacturing stock out
Skills:
5-7 years applicable experience in pharmaceutical manufacturing, Medical Device, or related industry including 1 year in Quality Assurance.

REQUIRED SKILLS:
  • Computer, Microsoft Office
  • Problem solving
  • Strong Written and Verbal communication
  • Strong math skills to include statistics

DESIRED SKILLS/EXPERIENCE:
  • Knowledge of external regulatory requirements and pharmacopeia (especially 21CFR210/211/820, EU GMP, USP, Ph EU, JPAL)
  • LIMS and ERP Systems (JDE ARMS)
  • Authoring/approving ANDA/NDA/510K submissions and subsequent responses to regulatory bodies/ministry of health/Food and Drug Administration
  • Authoring compliance documentation such as Annual Product Reviews (APR) and Change Control

SPECIFIC EXPERIENCE WITH:
  • Facilitating external inspections audits by regulatory bodies/ministry of health/Food and Drug Administration
  • Conducting internal audits and/or supplier audits for pharmaceutical and/or medical device
  • Quality over site of supplier, operations, validations and documentation
  • Drug/device labeling requirements (both US and international)
  • General chemistry and/or microbiology methods and laboratory operations
  • Manufacturing process and analytical method validation
  • Training other associates
Bachelors of Science in Biology, Chemistry and/or
Speciality training and certification in Pharmacy, Regulatory and Document Management

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