Regulatory Compliance Professional

6 days ago


Rockville, Maryland, United States PSC Biotech Full time
Life Science Assurance Specialist Job DescriptionPSC Biotech is seeking an experienced Validation Engineer to join our team. As a Life Science Assurance Specialist, you will play a critical role in ensuring the quality and regulatory compliance of our clients' products. The ideal candidate will have advanced knowledge of risk-based validation approaches, quality management, and regulatory requirements and compliance.

The estimated salary for this position is $95,000 - $120,000 per year, depending on location and experience. In addition to a comprehensive benefits package, we also offer opportunities for professional growth and development.

Responsibilities and RequirementsKey responsibilities of the Life Science Assurance Specialist include:
  • Developing and executing commissioning, qualification, and validation strategies and protocols in the life sciences/pharma/biotech industries.
  • Supporting validation planning, development, documentation, and execution.
  • Ensuring regulatory standards and quality requirements are met.

Desirable Skills and QualificationsTo be successful in this role, you should possess the following skills and qualifications:
  • Ability to travel as needed for project assignments and client engagements.
  • Strong technical background, with proven experience developing and executing commissioning, qualification, and validation strategies and protocols.
  • Advanced knowledge of risk-based validation approaches, quality management, and regulatory requirements and compliance.
  • Adaptability and flexibility, with the ability to work collaboratively with colleagues from diverse cultural backgrounds.
  • Problem-solving and analytical skills, with the ability to approach complex issues critically and find effective solutions.
  • Strong communication and collaboration skills, with the ability to work effectively in a team-oriented environment.

Our BenefitsPSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, employee assistance programs, 401(k) matching, PTO, sick time, and paid holidays, education assistance, pet insurance, fitness benefits, and financial perks and discounts.

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