Quality Control Technical Specialist

Description Helps maintain all QC Lab equipment in proper operational state, calibrated and qualified to include the equipment operating software packages. Perform a wide variety of activities to establish and ensure compliance with quality systems, quality procedures and policies and regulatory requirements to facilitate compliance with the agencies and customers. Provides training for new employees to the QC lab using approved documentation Develop, implement and maintain programs and processes to ensure high quality products and compliance with ICH, GMP, GLP and a safe & clean lab operation. Help with the maintenance of QC Lab documentation SOP''s, methodology, specifications, calibrations sheets, logbooks, etc. through change control, when needed. Lead or participate in focused deviation cross-functional investigations, improvement projects and other initiatives. Help identify Continuous Improvement Opportunities and perform their implementation. Implement management''s strategies and activities related to assuring compliance with regulations and ensure the company''s data integrity. Provide support for QC operations information during agency inspections as requested by QC manager. Manage ordering through SAP inventory management system. Investigate vendor options; ensure timely ordering procedures for consumable and chemical supplies; establish service contracts (such as for annual preventive maintenance of analytical instruments) In process samples testing record review and approval for release, when needed. Aid with retains & Stability testing program oversight, when needed. Quality systems support, including but not limited to: Investigation Support, Labeling, complaints, document control, training, CAPAs & Annual Product Reviews. When required. Participates in product development support, including but not limited to: Methodology Transfers, Stability program, project management, excel validations, oversight of special studies supporting regulatory filings and data/record retrieval for regulatory submissions. Prepare protocols, reports, metrics trend reporting, validation, logs & other documentation as needed. Help with review of manufacturing batch records. Other quality activities in support of the product as necessary & agreed upon. Qualifications Working knowledge of laboratory instrumentation to include GC, ICP-MS, IR, Karl Fischer, PH, UV-VIS, Density, Auto-titration and Refractive Index. Experience in analytical method development, method transfer and validation. Experience in supporting FDA, EU, Corporate & other regulatory audits. Experience in writing SOPs, test methods and reviewing validation protocols in a pharmaceutical manufacturing laboratory environment. Experience with deviations, investigations & change controls. Proficiency with computer office tools (Word, Excel, LIMS, Outlook & scientific databases, etc.) is required. Ability to work in a fast paced environment and manage priorities & maintain timelines for multiple projects is essential. Knowledge of ICH, GLP & GMP guidelines & their applications. Needs to be highly motivated and flexible, with excellent problem solving skills. Advanced verbal, technical writing and interpersonal communication skills. B.S. in Chemistry or scientific discipline is required. Minimum 3 plus years'' experience working in a pharmaceutical QC manufacturing laboratory environment with emphasis utilizing Gas Chromatography. Strong documentation skills. Some knowledge of Pharmaceutical regulations & audit experience a plus.

Created: 2025-10-04