Quality Assurance Support

2 months ago

Indianapolis, United States Barrington James Full time

QA Support Specialist - On-site (6 Month)


I am partnered with a biotechnology research company that is at the forefront of innovative research and development, dedicated to transforming scientific discoveries into impactful healthcare solutions. They are committed to excellence which drives their mission to advance human health and well-being through cutting-edge biotechnology research.


We are seeking a detail-oriented and motivated QA Support Specialist to join the Quality Assurance team. The successful candidate will play a crucial role in quality event management and tracking, with a primary focus on Corrective and Preventive Actions (CAPA), deviations, and change control. Proficiency in using electronic Quality Management Systems (eQMS), particularly ETQ software, is essential.


Key Responsibilities:

Quality Event Management:

  • Monitor, track, and document quality events, ensuring timely investigation and resolution.
  • Facilitate root cause analysis and develop effective CAPA plans to address identified issues.
  • Ensure CAPA actions are implemented, tracked, and verified for effectiveness.

Deviations:

  • Review and assess deviation reports to determine compliance with regulatory standards and internal procedures.
  • Coordinate investigations to determine the cause of deviations and implement appropriate corrective actions.
  • Maintain accurate records of deviation investigations and resolutions in the eQMS.

Change Control:

  • Manage change control processes to ensure that all changes are evaluated, documented, and approved in accordance with company policies and regulatory requirements.
  • Track and monitor change requests from initiation through implementation, ensuring timely completion and compliance.

eQMS (ETQ Software):

  • Utilize ETQ software to manage quality events, CAPA, deviations, and change control processes.
  • Provide training and support to team members on the effective use of the eQMS.
  • Ensure data integrity and accuracy within the eQMS, generating reports and metrics as needed.

Compliance and Continuous Improvement:

  • Stay current with industry regulations, guidelines, and best practices related to quality assurance and biotechnology research.
  • Participate in internal and external audits, providing documentation and support as required.
  • Identify opportunities for process improvements and contribute to the development and implementation of quality initiatives.

Qualifications:

  • Bachelor’s degree in Life Sciences, Biotechnology, Quality Assurance, or a related field.
  • Minimum of 2 years of experience in quality assurance within the biotechnology or pharmaceutical industry.
  • Strong understanding of CAPA, deviation management, and change control processes.
  • Proficiency in using electronic Quality Management Systems (eQMS), specifically ETQ software.
  • Excellent analytical, organizational, and problem-solving skills.
  • Strong communication skills, both written and verbal, with the ability to collaborate effectively across departments.
  • Detail-oriented with a commitment to maintaining high standards of quality and compliance.



Contract Details:

  • Duration: 6 months
  • Please note that we can’t provide H1B sponsorship for this role

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