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Quality Assurance Specialist

2 months ago

Cambridge, United States Medix™ Full time

Job Overview:

We are seeking a detail-oriented and proactive Quality Assurance (QA) Associate with a strong focus on Change Controls to join our dynamic team. The QA Associate will play a crucial role in ensuring that all changes within the organization, especially those affecting product quality and compliance, are managed efficiently and in accordance with regulatory requirements. This position offers the opportunity to work in a fast-paced environment at the forefront of biotech innovation.


Key Responsibilities:

Change Control Management:

  • Review and assess change control requests for impact on product quality, regulatory compliance, and overall operational processes.
  • Coordinate and facilitate the change control process, ensuring all changes are documented, evaluated, and implemented according to company SOPs and regulatory standards.
  • Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Control to ensure changes are implemented effectively and timely.
  • Monitor the implementation of approved changes and ensure proper closure of change control records.

Documentation and Compliance:

  • Ensure all change control documentation is accurate, complete, and maintained in accordance with company policies and applicable regulatory requirements.
  • Assist in the development and maintenance of SOPs related to change control processes.
  • Support internal and external audits by providing necessary documentation and explanations related to change controls.

Risk Assessment and Mitigation:

  • Conduct risk assessments to identify potential impacts of proposed changes on product quality and compliance.
  • Recommend appropriate mitigation strategies to minimize risks associated with changes.
  • Continuous Improvement:
  • Participate in continuous improvement initiatives aimed at enhancing the change control process and overall quality systems.
  • Provide training and guidance to other team members on change control procedures and best practices.


Qualifications:

Education: Bachelor’s degree in a Life Science, Biotechnology, or related field.


Experience:

  • 2-4 years of experience in Quality Assurance, preferably in the biotech or pharmaceutical industry.
  • Hands-on experience with change control processes in a regulated environment (e.g., FDA, EMA).


Skills:

  • Strong understanding of quality management systems and regulatory requirements (e.g., GMP, ICH guidelines).
  • Excellent organizational skills with a high level of attention to detail.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills, with the ability to work collaboratively across departments.
  • Proficiency in using electronic quality management systems (eQMS) and document management systems.