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Quality Assurance Specialist

2 months ago


Warren, United States Innova Solutions Full time
Job Title: Quality Assurance Specialist

Innova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our IT systems and processes.

Key Responsibilities:
  • Ensure accurate and timely maintenance of validation and qualification documents for all equipment and facility activities.
  • Investigate and evaluate change control to ensure compliance with regulatory requirements.
  • Provide QA oversight on key software development life cycle (SDLC) processes, including problem, incident, change, release, and deviations.
  • Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
  • Assure the appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
  • Support ECQ, Facilities, QC, and manufacturing equipment-related investigations to ensure appropriate and thorough impact assessment, root cause analysis, and corrective/preventive actions are documented and implemented.
  • Ensure compliance with the site validation master plan and assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
  • Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
  • Sponsor and support the change initiatives and the implementation of process improvement initiatives.
  • Ensure site compliance with global and regulatory data governance and data integrity requirements.
Requirements:
  • B.S. degree required.
  • 8+ years of experience in the pharmaceutical or related industry required.
  • Advanced knowledge and experience with GMP, Quality, and compliance.
  • Previous experience as a computer system validation/quality assurance for a life sciences company regulated by the FDA is preferred.
  • Advanced level experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing, and other equipment/facility qualification documentation.
  • Fluency in standard Microsoft Office software and experience in asset management software (e.g., Blue Mountain RAM) and quality systems software (e.g., Veeva).
  • Ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Intermediate knowledge of quality systems, including CAPA, change control, and document management systems.
About Innova Solutions:

Innova Solutions is a global leader in technology and business transformation solutions. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. Our company values include a commitment to quality, compliance, and customer satisfaction.

We are an Equal Opportunity Employer and prohibit any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where we operate.