QA Compliance Specialist

Description

The Compliance Specialist is responsible for overseeing critical aspects of the organization's quality management systems, including Change Control, Corrective and Preventive Actions (CAPA), Supplier Systems, and participation in the Quality Council. This role ensures that all compliance activities align with regulatory requirements and internal policies, supporting continuous improvement initiatives. The Compliance Specialist will play a key role in ensuring that processes are compliant, efficient, and effective in maintaining the organization's overall quality standards.

Key Responsibilities:

• Change Control Management:

  • Oversee and manage the Change Control process to ensure compliance with regulatory standards (e.g., FDA, ISO, GMP).
  • Review and track change requests, ensuring proper documentation, risk assessments, and evaluations of potential impacts on product quality and compliance.
  • Monitor the implementation of approved changes, ensuring adherence to timelines and regulatory requirements.

• Corrective and Preventive Actions (CAPA):

  • Oversee and manage the CAPA process to ensure compliance with regulatory standards (e.g., FDA, ISO, GMP).
  • Monitor the implementation and approval of CAPAs
  • Maintain accurate CAPA records and generate reports for senior management and regulatory authorities.

• Supplier Systems Oversight:

  • Ensure that supplier systems comply with all applicable regulations and quality standards.
  • Collaborate with procurement and quality teams to ensure proper supplier qualification, requalification, and the resolution of quality-related issues.
  • Support the development and maintenance of supplier quality agreements and ensure alignment with regulatory and organizational standards.

• Quality Council Participation:

  • Actively participate in the organization's Quality Council meetings, providing insights and recommendations related to compliance and quality management systems.
  • Collaborate with cross-functional teams to drive continuous improvement initiatives and resolve systemic quality issues.

• Documentation and Reporting:

  • Maintain and manage all compliance-related documentation, including Change Control records, CAPA reports, supplier quality, and Quality Council meeting minutes.
  • Ensure that documentation is up-to-date, accurate, and readily available for review by internal and external stakeholders.
  • Generate and present regular compliance reports, including key performance indicators (KPIs), for senior management and regulatory bodies.

Qualifications

Qualifications:

• Education:

  • Bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs, or a related field. Advanced certifications (e.g., ASQ, Six Sigma, or GxP) are a plus.

• Experience:

  • Minimum of 3-5 years of experience in compliance or quality assurance within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
  • Solid understanding of Change Control, CAPA processes, supplier quality management, and participation in cross-functional teams such as a Quality Council.
  • Knowledge of regulatory standards such as FDA, ISO 13485, cGMP, and other applicable guidelines.

• Skills:

  • Strong attention to detail with excellent problem-solving and analytical abilities.
  • Proven ability to manage multiple priorities, meet deadlines, and handle complex compliance issues.
  • Proficient in Microsoft Office Suite and quality management software (e.g., TrackWise, Veeva Vault, MasterControl).
  • Strong communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and management.

Salary : $60,000 - $70,000