SR..ceintest

Managed R&D lab and developed team of 30 chemists. Duties included documentation and internal audits, report reviews, SOP and method validation reviews and employee recruitment and training. • Ensured on-time release of product to meet clinical trial timelines for Oxycodone and Acetaminophen Capsules, USP and Oxycodone tablets by meeting with development team on a weekly basis. • Ensured other approved products passed FDA requirements and were in compliance. • Reviewed instrumentation calibrations to ensure accurate readings. • Met lab regulatory requirements by conducting monthly SOP reviews. • Met an aggressive submission deadline for Tamoxifen Citrate Tablets, effective in the treatment of metastatic breast cancer in women and men, by working cross functionally to accelerate department document review and approvals. Compliance Officer 1991 – 2005 Managed documentation and release activities to ensure compliance with FDA requirements. Developed, initiated, maintained, and revised policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Collaborated with other departments (e.g., Risk Management, Internal Audit, Employee Services, etc.) to direct compliance issues to appropriate channels for investigation. • Ensured timely release of numerous FDA approved products by creating a time-table for chemists to follow to meet deadlines. • Facilitated compliance with SOPs, GMP, and other regulations by conducting reviews of reports and data documentation prepared by analysts. • Ensured documents and release spec sheets were FDA compliant by comparing data recorded to expected regulations. • Met USP requirements by reviewing all data and information produced by chemists to ensure they met specifications for Lab Supervisor 1987 – 1991 Managed lab activities specifically related to stability, quality control and raw material procurement. • Promoted safety of lab workers by holding meetings to ensure chemists were following lab procedures and regulations and that all chemicals were properly labeled and stored. • Trained chemists to follow SOP’s, chemical analyses, and FDA regulations. • Ensured instrumentation functionality by conducting routine calibration exams. QC / RD Chemist 1984 – 1987 Managed chemical analyses of QC and stability test work for raw material lab. Prepared instructions for plant workers, monitored automated processes to ensure proper product yield, and tested samples of raw materials or finished products to ensure that they meet industry and government standards. • Recognized for setting particle size analyses for all raw materials used in the company. • Created a cleaning process for HPLC columns facilitating reuse cost reductions

Agricultural Technician

Newburgh, NY