Quality Assurance Specialist

6 days ago

Cincinnati, Ohio, United States Thermo Fisher Scientific Full time

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring compliance with established quality assurance processes, standards, federal and global regulatory guidelines, and client contractual obligations. This position reports to the Quality Compliance Manager.

Key Responsibilities:

  • Independently completes all aspects of regulatory inspections, customer audits, and internal audits, including scheduling, documentation preparation, SME coordination, hosting, follow-up responses, and audit closure.
  • Ensures on-time completion of audit activities with demonstrated interpersonal skills.
  • Interprets FDA and international regulations, Standard Operating Procedures, and company policies for regulatory compliance. Maintain continuous education of current regulatory requirements.
  • Partners with area leaders and subject matter experts for audit activities. Provides audit and inspection training as needed.
  • Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety Guidelines.
  • Maintains the necessary compliance status required by company and facility standards.

Quality Compliance:

  • Responsible to initiate and maintain GMP questionnaires with vendors.
  • Coordinate with quality, procurement, operations, and R&D globally to perform vendor audit activities.
  • Quality Agreements: initiation, review, and issuance for Commercial and Development Clients.
  • Quality Agreements database periodic review to perform periodic reviews as identified.

Requirements:

  • Clearly and accurately communicates in written and verbal form.
  • Applies excellent problem-solving skills with a logical approach to resolutions.
  • Strong decision-making skills.
  • Ability to prioritize multiple ongoing activities, and to prioritize tasks.
  • Outstanding attention to detail and organizational skills.
  • Highly effective verbal and written communication skills at all levels.
  • Excellent interpersonal skills to establish and maintain effective working relationships with employees and clients, including tact to handle critical matters.
  • Ability to work in a fast-paced environment.
  • Ability to maintain and manage high degree of confidentiality.

Education and Experience:

  • Bachelor of Science (B.Sc.) is preferred, or 4+ years of validated experience in GMP, GDP compliance and regulatory within the pharmaceutical industry.
  • 3+ years in Pharmaceutical Industry preferably within the Quality Compliance, QA, Engineering, or Project Management.
  • Extensive knowledge of GMPs, GDPs and Regulatory Affairs.
  • Experience working with various clients is preferred.

Our Values:

  • Integrity
  • Innovation
  • Intensity
  • Involvement

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