Scientist - Process Compliance / Manufacturing Support Specialist

• सित॰ 2019 - - वर्तमान

Quality Engineer

• फ़र॰ 2019 - सित॰ 2019

QA Supervisor - Pharmaceutical Ingredients

• अप्रैल 2017 - जन॰ 2018

Oversaw Quality Operations in Pharmaceutical Excipient repackaging/manufacturing facility. • Managed a Team of 2 QA Specialists• Authored SOPs, Batch Records• Assessed incoming material specifications against global compendia monographs• Created and delivered first root cause analysis (RCA) training to all Quality employees• Collaborated with External Quality to drive improvements with Supplier Qualification • Key adviser to management on ICH, USP-NF, EP, JP compendial and 21CFR regulatory guidelines• Hosted Seven site qualification audits for new/existing suppliers; owned all CAPA/audit responses

Technical Area Lead

• अग॰ 2015 - जन॰ 2017

Managed a team of 14 Manufacturing Personnel in Solid Dose aqueous/solvent Coating unit operation; process throughput on avg. 10MM doses/shift from portfolio of 40+products• Maintained department compliance to internal SOPs as well as FDA, OSHA, and DEA regulations• Reviewed manufacturing data on paper (MBR & Logbooks) and database entries (LIMS & ERP) to verify accuracy and completion according to ALCOA principles• Administered hands-on EH&S training to employees and ensured timely completion of assigned CBT in digital LMS• Held auxiliary function as a technical writer, leading investigations to determine root causes of systematic issues• Assisted with documentation and implementation of Change Control & CAPA activities• Played an active role in document control, assisting with SOP generation and revision• Used ERP software for MM and IM, Maintained accurate stocks of intermediate and finished material• Utilized cross functional relationships regularly with QA/QC, Engineering/Maintenance, PD, Manufacturing Tech Services, and Scheduling/Supply Chain• Publicly acknowledged employee achievements to build confidence and support team morale when working towards tough goals on tight timelinesKey Accomplishments• Earned the respect of employees and management. Earned a track record as an exemplary leader and hard worker. • Developed excellent competency with SAP; provided technical support for employees in their end user role. • Maintained a safe and injury-free work working area. No on the job injuries were reported for entire 16-month employment period.• Completed 36 technical investigations during employment period, approximately 20% directly supported new product launches in both Q2 and Q3 of 2016.• Supported a 95% on-time delivery rate of finished lots to inventory in 2016. This monthly metric judges overall success in meeting departmental output committed to at start of month.