Highlights:

Skills:

Field Quality Assurance (QA) Operations Specialist 02/2022 - 08/2023
Bristol Myers Squibb, Devens, MA United States
? Ensured manufacturing compliance in 95% of Standard Operating Procedures (SOP), Work Practices (WP), and Work Instructions (WI) with applicable procedures and batch records. ? Reviewed 120 cell therapy manufacturing electronic batch records and cleaning logbooks in real-time.
? Ensured manufacturing compliance in 95% of Standard Operating Procedures (SOP), Work Practices (WP), and Work Instructions (WI) with applicable procedures and batch records. ? Reviewed 120 cell therapy manufacturing electronic batch records and cleaning logbooks in real-time. ? Resolved critical quality issues with manufacturing by leading cross-functional collaborations with MS&T, Digital plant, Kitting, and Supply chain resulting in lowering the overall site quality metrics. ? Aided in GMP (Good Manufacturing Practices) walkthroughs with manufacturing, and being responsible for quality processes, reviewing, and approving deviations.--
Manufacturing Technology Representative 03/2021 - 02/2022
Catalent Pharma Solutions, Bloomington, IN United States
? Oversaw the drug product manufacturing operations providing regulations insights, ensuring compliance, and 4 data monitoring systems. ? Supported daily 5-7 external and internal clients’ communications for MS&T as a first point of contact. ? Problem-solving experience with difficulties in parenteral manufacturing through Rapid Response Calls participation and 6 cross-functional team interactions.
? Oversaw the drug product manufacturing operations providing regulations insights, ensuring compliance, and 4 data monitoring systems. ? Supported daily 5-7 external and internal clients’ communications for MS&T as a first point of contact. ? Problem-solving experience with difficulties in parenteral manufacturing through Rapid Response Calls participation and 6 cross-functional team interactions. ? Organized shift meetings, and shift notes, and supported in conducting shift exchange meetings. ? Gained knowledge of aseptic manufacturing, parenteral drug product operations, and cGMP compliance.--
Manufacturing Process Associate 06/2020 - 03/2021
Thermo Fisher Scientific, Millersburg, PA United States
? Utilized Work Instruction Documents (WID), SOP, SWP, and delivered visual controls for compiling weekly 2-3 thousand single-use bags from 5-5000 liters using floor-traveler. ? Implemented legible and accurate documentation as per cGMP guidelines for FDA traceability. ? Classified, cultivated, and executed Continuous Process Improvements (CPI) during the production of 2D/3D medical bio-reactor bags & tubing sets for different medical device and pharmaceutical industries.
? Utilized Work Instruction Documents (WID), SOP, SWP, and delivered visual controls for compiling weekly 2-3 thousand single-use bags from 5-5000 liters using floor-traveler. ? Implemented legible and accurate documentation as per cGMP guidelines for FDA traceability. ? Classified, cultivated, and executed Continuous Process Improvements (CPI) during the production of 2D/3D medical bio-reactor bags & tubing sets for different medical device and pharmaceutical industries. ? Leveraged Kaizen, RCCA, and One-Piece Flow to develop a standardized process to reduce waste by 30%.--

Savitribai Phule Pune University 08/2012 - 06/2016
Lonavala, Maharashtra, India
Degree: Bachelor's Degree
Major:Mechanical Engineering
Grade: First Class (60.65/100) Activities and societies: - Art of Living (Volunteer) - ISHRAE Student Chapter (Volunteer)

Ankit A Mehta Resume