QA Associate, Regulatory Compliance Specialist

Seattle, Washington, United States


SUMMARY:

The QA Associate III (Regulatory Compliance Specialist) is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements. This role requires attention to detail, organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent.

PRINCIPAL RESPONSIBILITIES:

  • Support with Regulatory Inspection Readiness
  • Inspection Preparedness
  • Maintain inspection readiness through inspection preparedness program and periodic readiness verification
  • Execute against plan (training, document readiness, response preparation and readiness)
  • Maintaining the Quality Systems in compliance with cGMP, FDA and ICH applicable regulations.
  • Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
  • Create and update SOPs, company Policies and other GMP documents.
  • Support the internal audit program
    • Maintain the internal audit schedule
    • Coordinate with internal auditors
  • Support the program to pro-active management of clients to ensure confidence in Quality systems including:
    • Support establishing Quality Agreements with clients consistent with Global standard.
    • Ensure communications with client are maintained consistent with Quality Agreement and positive client experience
    • Support required client audits and provide observation responses consistent with timeline commitments
    • Support Compliance Documentation and Licensing
  • Establish a calendar to provide visibility to compliance documentation requirements
  • Generate and provide required documentation to clients and Regulatory authorities
  • Other duties, as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong understanding of cGMP’s and concepts in several quality systems.
  • Demonstrated ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
  • Strong oral and written communication skills.
  • Ability to negotiate needed actions and manage difficult interactions effectively.
  • Knowledge of computerized support tools and software for audit tracking and reporting.
  • Demonstrated knowledge of root cause/trend analysis/risk analysis.
  • Demonstrated knowledge of quality processes and compliance.
  • Demonstrated ability to multi-task and work on several projects and problems
  • Ability to work under only general direction
  • Ability to independently determine and develop approach to solutions

EDUCATION/EXPERIENCE:

  • BA/BS in Biology, Chemistry or similar Science education. MS degree preferred
  • 5+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of 3 years of experience within Biopharmaceutical industry
  • Prior auditing experience preferred