Skilled Lead Production Technician bringing 20+ years of hands-on experience in the pharmaceutical manufacturing environment.
Diligent and reliable professional who maintains focus on safety, quality and compliance. Solid ability to work efficiently independently and as part of a team. Constantly willing to learn and accept new tasks and assignments, able to grasp new concepts quickly.
Coordinate and assist technicians in Coating, Compression and Encapsulation areas. Work closely with management to schedule daily activities in order to adhere to production schedule. Ensure that technicians are properly trained on SOP's and Batch Records as relates to process. Collaborates with MS&T during validation activities. Performs in process quality inspections throughout the production process. Assign technicians based on skill set and perform processing activities whenever staffing is limited in order to meet production needs.
Provides aid in setting up, breaking down, troubleshooting and minor repair of production equipment and stages product and prepares Batch Records to ensure readiness for processing. Monitors manual and electronic documentation during processing to aid in error reduction. Delivers feedback to management on personnel performance and behavior when necessary.
Performed assembly and operation of Fette single and double sided tablet presses and performed in processing testing and sampling in accordance with FMR, cGMP and related SOP's.
Served as a member of a High Performance Quality Team and helped to increase Right First Time as well as performed real time review of FMR's, Cleaning Procedure Checklists and logbooks to reduce errors.
Responsible for managing and assisting manufacturing associates in tablet press preparation and operation. Reviewed Batch Records and in process data sheets for completeness and accuracy. Communicated daily with supervisors, planners warehouse personnel and other department leads on production issues and requirements. Operated tablet presses and encapsulation equipment when required to meet production deadlines.
Operated capsule banding machines, Zanasi Capsule filling machines as well as Courtoy and Fette tablet presses. Performed in process testing using various gauges and calipers. Performed disassembly, cleaning, assembly and minor machine repairs. Prepared gelatin solution used in capsule banding process.
Operated and performed minor machine repair on equipment used in mail inserting of coupons and product samples.