Regulatory Compliance Officer II

3 weeks ago


Petersburg, United States BioSpace, Inc. Full time
About Civica: We are committed to addressing critical issues affecting the US healthcare system by bridging gaps in the generic drug supply chain. By partnering with esteemed institutions, we bring innovative solutions to life.

Job Summary: As a seasoned Quality Assurance Specialist, you will play a pivotal role in developing and implementing high-quality processes that adhere to strict regulatory standards. With your exceptional skills in Quality Risk Management, you will drive business success and foster long-term partnerships.

Key Responsibilities:
  • Promote a culture of compliance throughout the organization, emphasizing the importance of quality and safety.
  • Support continuous improvement initiatives by identifying areas of opportunity and collaborating with cross-functional teams to optimize processes.
  • Conduct thorough risk assessments to minimize potential hazards.
  • Analyze complex data sets to inform strategic decisions.
  • Collaborate with senior leadership to develop effective quality policies and procedures.

Requirements:
  • Bachelor's degree in a scientific discipline with 6+ years Quality/cGMP experience in the pharmaceutical industry.
  • Proven track record in process validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management.
  • Knowledge of 21CFR Part 11, Electronic Records and Signatures, and data integrity principles.

Estimated Salary: $120,000 - $180,000 per year.

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