Manager - Quality Control

InvaGen Pharmaceuticals, Inc., is seeking a Quality Control (QC) Manager in Central Islip, New York.

Job Description: Maintain current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). Plan the quality control routine operations and stability studies to ensure timely completion of stability studies and smooth functioning of release activity. Monitor the commitment dates for release of RM, PM, FP & water analysis and process and cleaning validation section by conducting performance dialogues and handshake. Review the plans prepared and monitor timely execution of activities in all the shifts to avoid delays. Review the monthly planner and production plans to ensure timely availability of required resources and ensure no sample is overdue. Monitor the execution of all routine quality control operation and stability studies to ensure timely delivery and meet regulatory requirements and cGMP, GLP guidelines. Monitor routine and stability operations closely and ensure that all necessary SOPs are followed by the team. Provide technical guidance related to troubleshooting in chromatography, experimentation design etc to minimize non-conformances. Monitor timely implementation of new updates in specifications and QCPs to meet compliance. Perform online review of reports generated to ensure zero data integrity issues in Lab. Monitor sample charging and sample pull-out as per schedule. Monitor reserved samples storage and destruction as per schedule and perform UD release. Monitor the stability chamber daily for excursions and other related issues. Drive the investigation of the batch for non-conformance and ensure its closure within the timelines defined in SOPs to facilitate smooth operations. Evaluate root cause analysis in case of OOS, OOT, incidences and rejection and propose CAPAs. Investigate the stability chamber excursions and propose CAPAs. Ensure that all non-conformances are routed through proper channel and are investigated as per SOP. Communicate with respective QC and QA heads for compliance and ensure timely closure of CAPAs by tracking in SmartSolve. Monitor completion of stability studies as per protocol/schedule to avoid delays in product launch. Perform analysis for stability samples without any errors as per schedule. Ensure timely completion of ANDA samples testing and submission of data by verifying it with ANDA schedule. Plan the routine and stability activities by coordinating with ADL/R&D about dates of product dossier filing. Resolve analytical and product related issues by escalating to ADL, R&D and transfer unit. Provide technical guidance to the team for batch release and stability studies and evaluate their performance to ensure team development and improved lab efficiency. Identify the training needs of employees based on the updates in the pharmacopeial guidelines. Monitor the training imparted on laboratory techniques, quality control procedures and principles of cGMP & GLP. Monitor the productivity of all the teams in the section by reviewing %SLA and %NC rates. Ensure the completion of training and qualification of analyst by taking feedback and timely reviewing his work.

Job Location: 550 South Research Pl, Central Islip, NY 11722

Salary: $184,080.00 per year

Minimum Requirements: The position requires a Bacheloras degree in Pharmacy, Chemistry, or related physical science field of study and Nine (9) Years of experience in a quality control role in a pharmaceutical organization. Position requires the following experience: Two (2) years of experience leading a team; Nine (9) years of experience with current Good Manufacturing Practices (cGMP) Good Laboratory Practice (GLP); Five (5) years of experience with raw materials and finished product testing and instruments and technologies, including Gas Chromatography, High-Performance Liquid Chromatography (HPLC), Karl Fischer (KF), Dissolution, Particle Size, and Ion chromatography; Four (4) years of demonstrated ability to lead and develop team members; Five (5) years of experience understanding and analyze complex data sets; Two (2) years of experience with Microsoft Office programs and other scientific based software.