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Sr. Quality Assurance Specialist

Indianapolis 90k-100k Permanent

Key Responsibilities:

  • Develop, implement, and maintain comprehensive quality management systems (QMS) in accordance with regulatory requirements and industry best practices.
  • Establish and document quality policies, procedures, and work instructions to ensure consistency and compliance across all operations.
  • Conduct regular reviews and assessments of the QMS to identify areas for improvement and optimization.
  • Design and execute quality assurance processes, including risk assessments, root cause analysis, and corrective/preventive action (CAPA) plans.
  • Lead investigations into quality issues, deviations, and non-conformances, and implement effective corrective actions to prevent recurrence.
  • Monitor key performance indicators (KPIs) and metrics to track quality trends and drive continuous improvement initiatives.
  • Stay abreast of relevant regulations, standards, and guidelines (e.g., FDA, ISO, cGMP) and ensure organizational compliance.
  • Support regulatory inspections and audits by preparing documentation, facilitating interviews, and addressing inquiries from regulatory authorities.
  • Collaborate with regulatory affairs teams to assess and mitigate quality risks associated with product development, registration, and commercialization.
  • Develop and deliver training programs on quality principles, processes, and procedures for employees at all levels of the organization.
  • Provide guidance and support to cross-functional teams to ensure understanding and adherence to quality requirements and standards.
  • Review and approve quality-related documentation, including batch records, validation protocols/reports, and change controls, to ensure accuracy and compliance.
  • Maintain organized and up-to-date records of quality documentation and records for audit purposes.
  • Lead or participate in quality improvement projects to enhance processes, systems, and product quality.
  • Champion a culture of quality excellence and drive initiatives to foster a proactive approach to quality throughout the organization.

Qualifications:

  • Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred.
  • Minimum of 5 years of experience in quality assurance roles within the pharmaceutical, biotechnology, or medical device industry.
  • In-depth knowledge of quality management systems, regulatory requirements (e.g., FDA, ISO), and industry standards (e.g., cGMP, GLP).
  • Strong analytical skills and attention to detail, with the ability to interpret complex data and make data-driven decisions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and influence stakeholders at all levels.
  • Certification in quality management (e.g., Certified Quality Auditor, Certified Quality Engineer) is desirable.
  • Experience with electronic quality management systems (eQMS) and proficiency in quality-related software applications is a plus.
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