Packaging Operator Utility Worker
Resume:
Jessie Charles
Middletown, NY *****
****************@*****.***
Work Experience
Reliable Technician II
Strides Pharmaceuticals - Chestnut Ridge, NY
February 2019 to Present
• Detection of where maladjustments and impending breakdown of production machinery and equipment and of making rapid and effective repairs and replacements to maintain production and avoid downtime.
• Supervise lower classified employees within assigned department.
• Production and must also interface with Engineering and planning department to maintain efficiencies.
• Insuring proper and on time set up and operation of production equipment.
• All machinery within assigned department in proper running condition, correctly located and properly adjusted for production.
• Safely, following G.M.P. procedures, routine maintenance and training of lower classification mechanics.
• Rebuild and insuring proper preventative maintenance on equipment with department supervisor.
• Insuring safety regulations, equipment lock out procedure, wearing googles, face shields, proper safety clothing and shoes.
Lead Aseptic Operator / Aseptic Operator / Operator II Pfizer
2004 to 2016
Lead Operator of 20 Operator staff. Together with supervisor, ensure proper procedure guidelines are followed in syringe and vial fill manufacturing. Responsible for batch record review during and after process completion.
• Aseptic preparation, machine operating, packaging, and inspection of equipment. Worked both in the direct manufacture and packaging of Prevnar.
• Check syringe and vial turbidity using spectrophotometer. Perform bulk and component verifications.
• Maintain syringe and vial rejecter challenge-set to ensure Eisai machine properly selects defective product.
• Work in an aseptic environment including validation start of packaging lines. Observe and report irregularities in machine functions and sterile room conditions. Prepare and wrap equipment used in sterile operations.
• Work with Media Fill staff (incubation of syringe and vials) to assure product is of quality for injection. Serve as a backup for vial & syringe manual inspections to assure product quality.
• Adhere to stringent SOPs: line adjustments, grade classifications of aseptic techniques include A, B, C, D. Gown Certification.
• Secondary assurance of product: includes training and running batch records, and proofreading documentation.
Pharmaceutical Operator I
Pfizer
2002 to 2004
Experienced in pharmaceutical manufacturing and production, including weighing, blending, and compression in tablet and capsule production. Set up, operate, clean, maintain, and troubleshoot computerized machinery.
• Maintain batch records and logs. Report deviations from procedures to Supervisor. Packaging Operator
Pfizer
1995 to 2002
Served as OJT (Expert On Job Trainer); trained and skill-block checked employees.
• Set-up, maintained, operated, monitored, and cleaned production and packaging machines. Cleaned production rooms and areas. Changed, threaded, and spliced roll labels. Weighed rebulk according to standard formulations.
• Received, transferred, loaded, and unloaded bulk material into and out of mixers, dryers, and mills.
• Assembled filled, packed, sealed, and labeled packages and shipping cartons. Inspected all outbound materials for proper packaging, labeling, and paperwork. Maintained records and logs in compliance with SOPs.
Utility Worker, Consumer Health
Pfizer
1991 to 1995
Monitor and change charts (chill rooms, production areas), maintain records/logs, and document component check-in.
• Supply production lines and warehousing areas with gowning garments, production components, and materials.
• Clean and maintain work areas; dispose of waste and hazardous material.
• Operate manual and mechanized material handling equipment. Skills
• SOPS (10+ years)
• INSPECTION (10+ years)
• CGMP (Less than 1 year)
• CONTINUOUS IMPROVEMENT (Less than 1 year)
• FDA (Less than 1 year)
• Aseptic Technique
• Calibration
• Manufacturing
• Basic math
• Power tools
• Key skills and knowledge: Continuous Improvement, In Process Checks (IPC), Quality Assurance (QA), Product Verification Inspection (PVI), Workflow Prioritization, Consent Decree.
• Expert-On-Job-Trainer (EOJT) qualified to conduct Skill Block Checks.
• Trained in regulatory safety and compliance: FDA, OSHA, cGxPs (cGMP, GLP), SOPs, PMOs.
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