Quality Control Specialist

Job Summary:

The Quality Control (QC) Specialist will be responsible for ensuring the quality and compliance of pharmaceutical development study protocols and reports. This role involves the review and approval of documentation related to the development process, acting as a subject matter expert (SME) in the QC function, and coordinating with Contract Manufacturing Organizations (CMOs) to investigate deviations related to testing protocols. The ideal candidate will have extensive experience in quality control within the pharmaceutical industry, with strong analytical skills and a deep understanding of regulatory standards.

Key Responsibilities:

1. Review and Approval of Study Protocols and Reports:
   • Review and approve pharmaceutical development study protocols, ensuring they meet regulatory requirements and company quality standards.
   • Critically evaluate study reports to ensure data accuracy, completeness, and compliance with established protocols and industry standards.
   • Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to address any discrepancies or concerns identified during the review process.
2. Quality Control Subject Matter Expert (SME):
   • Act as the SME for the QC function, providing guidance and expertise on quality control best practices, methodologies, and regulatory requirements.
   • Lead and support the development and implementation of QC processes, procedures, and standards to ensure consistent quality across all pharmaceutical development activities.
   • Provide technical support and training to QC personnel and other stakeholders on QC principles, techniques, and regulatory expectations.
3. Regulatory Compliance:
   • Ensure all reviewed and approved documents comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards.
   • Stay current with changes in regulatory requirements and industry best practices, ensuring that study protocols and reports are updated accordingly.
   • Support regulatory submissions by providing QC-related documentation and expertise as required.
4. Coordination with Contract Manufacturing Organizations (CMOs):
   • Work closely with CMOs' Quality Control units to ensure that all testing activities are conducted in accordance with approved protocols and regulatory standards.
   • Investigate and resolve any deviations to testing protocols that occur at CMOs, ensuring a thorough understanding of the root cause and the implementation of corrective and preventive actions (CAPA).
   • Monitor and follow up on the effectiveness of CAPA implemented by CMOs to ensure continuous compliance and quality improvement.
5. Continuous Improvement:
   • Identify opportunities for process improvements in the QC review and approval process, and implement changes to enhance efficiency and effectiveness.
   • Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) related to QC activities.
   • Lead or support quality improvement initiatives, including root cause analysis and the implementation of corrective and preventive actions (CAPA).
6. Data Management and Integrity:
   • Ensure the integrity of all QC data by implementing robust data management practices, including proper documentation, storage, and retrieval processes.
   • Review and approve QC data generated during pharmaceutical development studies, ensuring that it meets the required standards for accuracy, precision, and reliability.
   • Support the implementation and maintenance of electronic systems (e.g., LIMS) used for QC data management.
7. Collaboration and Communication:
   • Work closely with cross-functional teams to ensure alignment on quality expectations and requirements for pharmaceutical development projects.
   • Communicate effectively with internal and external stakeholders, including providing clear and concise feedback on study protocols and reports.
   • Represent the QC function in meetings, discussions, and decision-making processes related to pharmaceutical development.
8. Training and Development:
   • Develop and deliver training programs for QC personnel and other relevant staff on quality control standards, procedures, and regulatory requirements.
   • Mentor and support the professional development of QC team members, fostering a culture of continuous learning and improvement.

•  Education: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Control or Quality Assurance is preferred.

• Experience:
  • 5+ years of experience in quality control within the pharmaceutical, biotech, or related industry.
  • Proven experience in reviewing and approving pharmaceutical development study protocols and reports.
  • Strong understanding of regulatory requirements for pharmaceutical development and QC (e.g., FDA, EMA, ICH guidelines).
  • Experience working with CMOs and managing deviations in a QC context.
• Skills:
  • Strong analytical and critical thinking skills with the ability to evaluate complex data and identify potential quality issues.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional 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 with electronic data management systems (e.g., LIMS).
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Experience in method development and validation in a QC setting.

Working Conditions:

• Office-based position with occasional travel to CMOs, manufacturing sites, external partners, or regulatory agencies as required.
• Ability to work effectively across different time zones as needed.