QC Laboratory Manager

Overview:

The QC Laboratory Manager is responsible for overseeing all aspects of the QC laboratory operations, ensuring that all testing conducted on raw materials, in-process samples, stability samples, and finished products comply with established quality standards and regulations, managing staff, monitoring quality control data, investigating out of specification results and deviations, managing laboratory procedures, maintaining accurate documentation, maintaining compliance with relevant regulatory bodies, and acting as a key liaison between the QC lab and other departments within the company.

Key responsibilities of the QC Laboratory Manager:

Leadership and Team Management:

• Lead, train, mentor, and supervise a team of laboratory analysts.
• Manage analyst scheduling and workload to meet testing deadlines.
• Foster a culture of quality and compliance within the laboratory.

Laboratory Operations and Compliance:

• Manage laboratory equipment, including calibration, maintenance, and qualification.
• Monitor and maintain laboratory inventory of all laboratory consumables and supplies (e.g., chemicals, reagents, standards, agars, glassware) to ensure uninterrupted laboratory workflow.
• Oversee sample receipt, handling, and analysis.
• Develop, implement, and maintain comprehensive quality control procedures, methods, and protocols to ensure accuracy and consistency of testing results.
• Maintain ongoing QC laboratory programs (e.g., stability, environmental monitoring, vendor qualifications, water testing, hazardous waste, preventive maintenance, data trending)
• Monitor and review quality control data to identify trends and potential issues, taking corrective actions when necessary.
• Ensure compliance with relevant regulations (e.g., GMP, GLP, FDA, USP) through regular assessments and documentation review.
• Investigate out-of-specification (OOS) results, deviations, and non-conformances, documenting findings and implementing corrective actions.
• Ensure compliance with all relevant safety regulations, including proper handling of hazardous materials and waste disposal.
• Review and approve test protocols, data analysis, and laboratory reports.
• Assist as needed in regulatory agency inspections and 3rd party audits.
• Respond to laboratory related audit findings and implement corrective actions.
• Implement and maintain data integrity practices in the laboratory.

Technical Expertise:

• Stay updated on the latest analytical techniques, methodologies, and industry standards to ensure the laboratory remains current.
• Stay updated on current regulatory requirements and industry trends.
• Troubleshoot technical issues with laboratory equipment and instrumentation.
• Possess in-depth knowledge of laboratory techniques, instrumentation, and data analysis methods.
• Subject matter expert on all QC laboratory related activities within the company.

Collaboration and Communication:

• Collaborate with other departments within the organization, including production, quality assurance, and regulatory, to ensure seamless integration and communication.
• Communicate effectively with other departments regarding testing results, deviations, and quality issues.

Required Skills and Qualifications:

• Bachelor's degree in chemistry or a related scientific field.
• Knowledge of microbiological methodologies.
• Experience in a pharmaceutical QC laboratory, preferably in a leadership role.
• Thorough understanding of pharmaceutical regulatory requirements and quality standards.
• Strong understanding of laboratory safety protocols and regulatory compliance.
• Proficient in operating, maintaining, and calibrating analytical instrumentation and developing and performing analytical test methods (e.g., HPLC, FTIR, UV-Vis, dissolution, wet chemistry techniques, density, pH, conductivity, particle size analysis, moisture analysis, and microbiology).
• Proficient in data analysis and interpretation.
• Proficient and thorough in writing technical documents, protocols, reports, and procedures.
• Excellent written and verbal communication skills.
• Strong critical thinking skills.
• Ability to work on multiple projects with competing priorities and tight deadlines with excellent time management.
• Must have meticulous attention to detail to ensure the accuracy of all documentation.

Pay: $65, $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $85,000