Manager, QC Lab Remediation

Manager, Quality Control Lab Remediation – Rensselaer, NY

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The QC Laboratory Remediation Manager is an integral part of the Curia team, contributing to our success by leading the QC lab remediation program. The laboratories test chemical intermediates, raw materials, active pharmaceutical ingredients, and stability of those products. The Manager will drive QC lab improvement initiatives to maintain regulatory compliance and implement continuous improvement. The role requires assessing gaps in existing QC lab systems, identifying simple and compliant solutions, implementing those solutions for routine operations, and leading the QC lab LIMS implementation.

Additionally, the Manager will develop robust CAPA plans and oversee training and qualification programs.

• Establish and maintain QC lab remediation and continuous improvement.
• Work with QC supervisors and the QC Manager to complete regulatory inspection and customer audit commitments in a timely manner.
• Trend QC lab performance metrics, identify areas of improvement, and implement robust CAPAs.
• Play a key role in the QC lab inspection readiness plan.
• Perform gap assessments for regulatory observation and implement CAPAs.
• Develop a compliant and practical training and qualification program in the lab, develop training metrics, and train the trainers.
• Perform periodic walkthroughs, identify potential themes, and drive systemic CAPAs with QC supervisors and manager.
• Update analytical methods, procedures, and training modules to drive improvements.
• Lead QC lab LIMS implementation, serving as a conduit between site QC operations, IT, and Global Quality Systems teams for master data development, procedural updates, and UATs.
• Establish new and improved ways to perform the job by challenging established procedures.

• Bachelor’s Degree in Chemistry or a relevant field.
• Minimum of 5 years of relevant experience, including 2 years in a team‑leadership role.
• Investigations experience, including root cause analysis, writing, and CAPA identification.
• Good understanding of GMP requirements for QC operations.
• Previous experience managing a QC team in a commercial product GMP environment.

• Advanced degree in Chemistry or a related field.
• Investigation experience in a laboratory setting.
• Pertinent training or courses.
• Experience in a cGMP QC environment.

• Ability to recognize what needs to be done, take action, and accomplish results.
• Strong oral and written communication skills, including effective listening.
• Demonstrated ability to effectively utilize team resources.
• Expert knowledge of cGMP, USP, EP, and FDA regulations.
• Technical competence, including understanding of theory and interpretation of lab techniques.
• Proficient use of computer software, including Microsoft Office Suite and other required software.
• Strong organizational skills with the ability to multitask.
• Prior knowledge of FDA GMPs (21 CFR 211, 820, and/or 600), ISO 9001 and 13485.

While performing the duties, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently reaches with hands and arms, occasionally stands, walks, climbs or balances, and stoops, kneels, crouches, or crawls. The employee must occasionally lift and/or move up to 50 pounds. Close vision and the ability to adjust focus are required.

The employee may be exposed to fumes or airborne particles and toxic or caustic chemicals; proper personal protective equipment is required. Exposure to wet and/or humid conditions, moving mechanical…