The Quality Investigator, reporting directly to the Senior Director of QC Chemistry, oversees the quality of QC Chemistry’s operations. The Quality Investigator is responsible for conducting investigations and for developing and implementing strategies to prevent future quality deviations. He or she will write and review deviations, out-of-specification lab investigations, and corrective and preventative actions (CAPAs). The Quality Investigator is responsible for leading a team of chemists in obtaining and maintaining superior quality metrics.
Primary Duties and Responsibilities
- Champion efforts to ensure all QC Chemistry’s work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration regulations, company mandates, client requirements, and pharmacopeial methodologies.
- Conduct root cause analysis and implement solutions in collaboration with the team.
- Write and review deviations, out-of-specification lab investigations, and CAPA lab investigations.
- Prioritize laboratory investigations to meet client requirements as related to quality, on-time performance, and turnaround time.
- Communicate investigation delays, quality, and/or technical issues to the Senior Director of QC Chemistry.
- Lead the development and implementation of process improvement initiatives that promote and improve the quality of project output.
- Manage QC Chemistry-related SOPs and processes. Implement or change SOPs and processes, as needed.
- Compile and maintain quality performance metrics and analyze trends.
- Review lab nonconformance with group leaders and chemists.
- Conduct routine metrics reviews and root cause analyses with group leaders and management.
- Train and mentor group leaders and chemists in their knowledge and application of investigational skills, CAPAs, and deviations, with the goal of minimizing deviations and investigations.
- Build strong relationships and participate in internal audits with the Quality Assurance department.
- Document work in a clear and organized manner.
- Follow safety and cGMP rules and regulations.
- Complete other duties as requested by senior management.
Qualifications include a PhD with 4 years of related experience, a Master’s with 6 years of related experience or Bachelor’s degree with 8 years of related experience. Knowledge of cGMPs and related compliance regulations and guidance’s required. Proven knowledge and application of tools like 6M, 5 Why’s, etc. Proven success with championing quality in a pharmaceutical environment.
Minimum Skills Requirements:
- In-depth knowledge of FDA pharmaceutical cGMP standards and related compliance regulations and guidance.
- An advanced understanding of lab safety, quality systems, and quality control concepts.
- Exceptional verbal and communication skills across all layers of an organization.
- Minimum Bachelor’s degree in chemistry, pharmacy science, or a closely related field.
- Significant work experience in chemistry laboratory analysis, quality control, stability studies, method transfer and verification.
- Intermediate to advanced skills in Microsoft Office, LIMS, ELNs, and various Chromatography Data Systems.
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