Lead Quality Control Analyst

Business: Critical Care
Department: Quality Control
Location: Bethlehem
Travel: None

Key Roles/Responsibilities:

• Helps maintain all QC Lab equipment in proper operational state.
• 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.
• Develop, implement, and maintain programs and processes to ensure high quality products and compliance with ICH, GMP, 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.
• In process samples testing record review and approval for release, when needed.
• Quality systems support, including but not limited to: laboratory investigations , deviation investigations , analyst training, and CAPA.
• 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, validation, logs & other documentation as needed.
• Facilitate meeting cycle times
• Manage white board to ensure analysts are scheduled with testing ensuring they meet the targeted TAT.
• Ensure that deviations and OOS investigations are being worked on and progressing to meet release dates for affected samples.
• Responsible for all management activities associated with the direct reports’ recruitment, training, scheduling and performance management.
• Maintain and collect data on internal KPI’s for QC employee efficiency data as required.
• Assist and back-up the QC Manager; reviews/approves and releases product, raw materials, and other test results.

• Working knowledge of laboratory instrumentation to include GC, GC-MS, ICP-MS,, IR, Karl Fischer, pH, UV-VIS, Density, Auto-titration, and Refractive Index.
• Experience in analytical method development, method transfer, method verification, and validation.
• Experience with laboratory instrument qualification, preventative maintenance, and calibration.
• Experience in supporting FDA, EU, corporate & other regulatory audits.
• Technical writing experience including writing SOPs, test methods, and authoring or reviewing protocols in a pharmaceutical manufacturing laboratory environment.
• Experience with deviation investigations, laboratory investigations, change controls, and CAPA.
• 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 FDA regulations, ICH guideline, and cGMP 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.