Scientist II

Interpret, apply, and ensure compliance with global regulatory requirements, cGMP, GLP, and data integrity standards. Initiate and support change controls and assist with documentation for compliance and regulatory requirements. Review test results for compliance with GMP, SOPs, and product specifications. Calibrate laboratory instruments to ensure accuracy and reliability of test results. Prepare certificates of analysis, protocols, reports, vendor qualification and compilation documents. Develop and revise Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs), General Testing Procedures (GTPs), and product specifications per USP guidelines and company requirements. Conduct compendial evaluations based on USP/NF revisions. Support regulatory submissions, query responses, and information requests. Procure laboratory supplies, including chemicals, USP standards, reference standards, and chromatographic columns. Communicate with vendors and Contract Testing Laboratories (CTLs) regarding testing requirements and timelines. Maintain inventory of chemicals and standards in LIMS; prepare worksheets and test plans per approved STPs and specifications. Perform and document laboratory testing of raw materials, in-process samples, finished products, stability studies, process validation, and R&D samples using advanced analytical techniques, including High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), UV/VIS Spectrophotometry, Dissolution Testing, Infrared Spectrophotometry, and Karl Fischer Titration. Record all data in Laboratory Information Management System (LIMS) and laboratory notebooks in accordance with company procedures. Manage receipt, storage, and logging of samples, including packaging, in process, finished product, stability, and R&D samples. Participate in internal audits and inspections by DEA, FDA, and customers. Provide mentorship and training to junior team members, when required. Applicants must have a Master's degree (or U.S. equivalent) in Pharmacy, Chemistry, or Pharmaceutical Sciences Three (3) years of experience in a pharmaceutical quality environment. The role requires hands-on experience with GxP documentation, change control processes, artwork review, and preparation of quality documents, including SOPs, STPs, specifications, and vendor qualification materials. Experience with regulatory audits, compliance documentation, and a strong understanding of the product release and quality lifecycle is required. Candidates must possess thorough knowledge of regulatory requirements, strong communication skills for interaction with customers and vendors, and proficiency in Microsoft Office, and technical writing.