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Quality Assurance Specialist

Indianapolis Competitive Permanent

Job Responsibilities:

  • Lead investigations for Out of Specifications results and implement corrective actions.
  • Ensure operational compliance with US and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
  • Investigate Exceptions to Standard Operating Procedures and implement necessary measures.
  • Generate and review Change Controls for Standard Operating Procedures, Test Methods, Data Sheets, etc.
  • Utilize quality tools (FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) for investigations and special projects.
  • Perform statistical analysis of laboratory data to support investigations, cost savings, and continuous improvement initiatives.
  • Develop, execute, and manage protocols for Method Validations and Equipment Qualifications, including work with radioactive materials.
  • Ensure a safe and quality working environment through training, awareness, and compliance with safety/quality guidelines and SOPs.
  • Stay updated on US and international regulations related to Microbiology, Chemistry, and cGMPs.
  • Provide support for on-site audits conducted by regulatory agencies (FDA, HC, EU, TGA, etc.).


Requirements:

  • Bachelor of Science in Biology, Chemistry, or a related field is required.
  • Three or more years of relevant experience is necessary.
  • Preferred experience in investigating exceptions and out-of-specification results.
  • Ability to resolve problems, handle conflict, make effective decisions under pressure, and conduct Root Cause Analysis.
  • Proficiency in simple to complex math calculations, data input, and analysis.
  • Strong multitasking skills to handle various projects simultaneously.
  • Proficient in the use of Microsoft Office suite.
  • Good computer skills, including data entry programs.
  • Hands-on, analytical, and effective problem-solving and decision-making skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently and collaboratively to achieve goals and priorities.
  • High energy level and consistent attendance.
  • Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.


Contact your Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Zhanri, directly:

  • Email: zdesphy@harbasolutions.com
  • Phone: 617.284.4255


About Harba Solutions:

Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.

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