QA Specialist

Job Summary:

The Quality Assurance Specialist will play a critical role in ensuring the quality and compliance of pharmaceutical testing activities. This position is responsible for the review and approval of testing protocols and reports, as well as coordinating with Contract Manufacturing Organizations (CMOs) to oversee investigations related to the execution of testing protocols. The ideal candidate will have a strong background in quality assurance within the pharmaceutical industry, with excellent attention to detail and a deep understanding of regulatory requirements.

Key Responsibilities:

1. Review and Approval of Testing Protocols and Reports:
   • Review and approve testing protocols, including stability, validation, and method development protocols, ensuring they meet regulatory requirements and company standards.
   • Critically evaluate testing reports to ensure the accuracy, completeness, and compliance of data, and to confirm that results align with the objectives of the protocols.
   • Collaborate with cross-functional teams, including Quality Control, Regulatory Affairs, and R&D, to address any discrepancies or concerns identified during the review process.
2. Coordination with Contract Manufacturing Organizations (CMOs):
   • Serve as the primary Quality Assurance liaison with CMOs, ensuring that all testing activities are conducted in accordance with approved protocols and regulatory standards.
   • Coordinate and oversee investigations related to deviations, non-conformances, or out-of-specification (OOS) results that occur during the execution of testing protocols at CMOs.
   • Ensure that CMOs implement appropriate corrective and preventive actions (CAPA) in response to identified issues, and verify the effectiveness of these actions.
3. Regulatory Compliance:
   • Ensure that all reviewed and approved documents comply with applicable regulatory requirements, including FDA, EMA, and other global standards.
   • Stay informed about changes in regulatory requirements and industry best practices, and ensure that protocols and reports are updated accordingly.
4. Investigation Management:
   • Lead and manage quality investigations related to the execution of testing protocols, including root cause analysis, CAPA development, and documentation.
   • Work closely with CMOs to ensure timely and thorough investigation of any issues, and to facilitate clear communication and resolution of quality concerns.
5. Documentation and Record Keeping:
   • Maintain accurate and organized records of all quality-related activities, including protocol and report reviews, investigation findings, and CAPA documentation.
   • Ensure that all documentation is controlled and maintained in accordance with company procedures and regulatory requirements.
6. Continuous Improvement:
   • Identify opportunities for process improvements in testing protocol execution, report review, and quality investigation practices.
   • Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) related to quality assurance activities.
7. Training and Compliance:
   • Provide training to internal teams and CMOs on quality standards, regulatory requirements, and best practices for protocol execution and reporting.
   • Ensure that all personnel involved in testing activities are adequately trained and that training records are maintained.

• Education: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Assurance is preferred.
• Experience:
  • 3+ years of experience in quality assurance within the pharmaceutical, biotech, or related industry.
  • Experience reviewing and approving pharmaceutical testing protocols and reports.
  • Familiarity with regulatory requirements for pharmaceutical testing (e.g., FDA, EMA guidelines) and experience in coordinating with CMOs.
• Skills:
  • Strong analytical skills with the ability to critically evaluate data and identify potential quality issues.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners.
  • Detail-oriented with a strong commitment to accuracy and regulatory compliance.
  • Effective problem-solving skills, particularly in the context of quality investigations and CAPA management.

Preferred Qualifications:

• Experience in managing quality investigations and conducting root cause analysis.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Knowledge of quality management systems and electronic document management systems (EDMS).

Working Conditions:

• Office-based position with occasional travel to CMOs or other partner sites as required.
• Ability to work effectively across different time zones as needed.