A Manager/Production and Process Supervisor/Project Manager/Technical Writer with more than fifteen years experience in an FDA-regulated environment. More than nine years supervisory experience and four years project management experience. Two years of Quality experience. Experience in chemical processing, sterile manufacturing, Upstream and Downstream processing, large-scale purification for parenterals, and Immunodiagnostics and Hemostasis Manufacturing and Quality Control for
A Manager/Production and Process Supervisor/Project Manager/Technical Writer with more than fifteen years experience in an FDA-regulated environment. More than nine years supervisory experience and four years project management experience. Two years of Quality experience. Experience in chemical processing, sterile manufacturing, Upstream and Downstream processing, large-scale purification for parenterals, and Immunodiagnostics and Hemostasis Manufacturing and Quality Control for the Medical Device Industry. Displays an excellent attention to detail, superior organizational skills, and the ability to coordinate and prioritize activities. Shows initiative, has the ability to self-manage and has proven the ability to motivate others.
Senior Specialist, Quality Assurance @ Review and Approval of Quality System Excursions, Deviations, CAPA’s, Effectiveness Reviews and Maintenance Work Orders
Approve validation strategies, FAT, SAT, IQ, OQ, PQ & PV validation protocols, and reports for equipment and processes. Responsible for the approval and in the development, as needed, in the preparation of specifications, design review, installation and startup of new equipment, design changes and modifications to existing equipment and utilities that support the equipment for aseptic processing.
Approve calibration records, maintenance plans and SOPs. Oversight and approval of formal change control (FUSE/eCC) and Maximo work orders for the site’s validated state of GMP Quality Systems.
Provide guidance for troubleshooting during validation activities as warranted, and review and analyze data generated during a validation.
QA oversight on validation and revalidation activities on a routine basis per schedule for maintaining equipment & processes in a validated state.
Experience with automation, SCADA and PLC systems.
Provides expertise in a variety of technical and GMP systems
Provide QA support and guidance for Packaging, Inspection, Warehouse and Incoming Quality Assurance
Support compliance audits
Lead investigations as required From August 2013 to Present (2 years 5 months) Production Supervisor, Bulk @ • Direct Supervision of up to eight direct reports of various education and skill level in two production suites
• Personnel Development and Performance Management of direct reports
• Identification, initiation, and investigation of deviations and Quality System Events through the use of Trackwise
• Review, Revision, and Creation of Master Batch Records, Work Instructions and Standard Operating Procedures
• Review of completed batch documentation and logbooks for GMP compliance
• Champion of process improvement initiatives
• Coordination and scheduling of equipment maintenance activities and creation of instructions for performance of maintenance activities
• Yellow Belt Certified From September 2009 to August 2013 (4 years) Senior Manufacturing Supervisor @ • Management and coaching of up to ten direct reports responsible for the manufacturing of Active Pharmaceutical Ingredient for phase II clinical trials. Responsible for the improvement of the efficiency and quality of products being produced in the manufacturing area. Worked towards phase III clinical trials and full GMP manufacturing.
• Aseptic filling for drug substance and aseptic inoculations.
• SME and designated trainer for upstream and downstream unit operations.
• Identification, initiation, investigation and closure of CAPA’s and deviations
• Review, Revision and Authoring of Master Production Records and Standard Operating Procedures.
• Performance and Management of Upstream and Downstream operations
• Reviewed batch records, solution records and ancillary paperwork used for manufacturing of product.
• Prepared production schedule, scheduled maintenance and preventive maintenance.
• Collaborated with multiple departments to ensure achievement of shared goals, including working with quality assurance, quality control, regulatory, maintenance and technical services.
• Led the Education and Training safety sub-team and represented this group on Biolex’ core safety team while working to raise safety awareness and to ensure compliance with required safety training. From April 2007 to November 2009 (2 years 8 months) Manager, Critical Component Manufacturing and QC Immuno @ • Review and execution of validation protocols and authoring of validation reports
• Responsible for the initiation, investigation, implementation, verification of effectiveness and closure of assigned CAPA’s
• Author and Trainer for Deviation waivers
• Initiation, investigation and closure of Nonconforming Material Reports, Out of Specification Investigations, and Out of Control Limit Reports
• Management of production schedule for Immunodiagnostics and Hemostasis Manufacturing in Critical Component Manufacturing Area
• Review of Manufacturing Batch Records
• Reviewer and Final Approval of FDA submission protocols for X-Kit submission of HIV-1 Improved, HIV-1 Oral Fluid and HTLV-I/II test kits
• Member of a cross-functional Immunodiagnostics Product line team (which included R&D, Manufacturing Technologies, Regulatory Affairs, Quality Control and Quality Assurance) that addressed product quality and safety issues, prioritized upcoming process validations and test method validations and tracked completion of FDA commitments
• Management and coaching of ten direct reports
• Support of Immunodiagnostics, BacT/Alert, and Hemostasis raw material testing and mini-piloting
• Successful Implementation of Lean Manufacturing Principle of 5S in Critical Component Manufacturing over three months which led to implementation of a production schedule, efficiencies gained through organization of supplies and equipment, ease in new employee training, and a clean, compliant work environment From 2005 to 2007 (2 years) Process Supervisor @ • Coordinated movement of laboratory processes into the Pilot Plant, to include scheduling of equipment, development of project timelines and goals, and authoring and review of appropriate documentation to support delivery of clinical API supplies
• Worked with diverse teams to accomplish tactical and strategic goals
• Provided documentation for supplemental processing steps, supplemental cleaning records, cleaning after maintenance records, and process qualification records for new equipment
• Developed, authored, revised and administered standard operating procedures
• Initiated and completed investigations and assigned corrective and preventive actions for deviation investigations and quality investigations
• Managed large-scale campaigns for API manufacturing in various therapeutic areas which yielded 30% more API than requested with a campaign completion two months ahead of schedule
• Created a system for separation of cleaning records from manufacturing records, which led to batch record review time being reduced by fifty percent
• Created a library of maintenance cleaning procedures, which improved work stream efficiency and eliminated non-value added activities From 2002 to 2005 (3 years) Manufacturing Supervisor/Associate @ • Management of assigned personnel
• Initiation and closure of exception reports, incident reports, and preventive action tracking records
• Review of manufacturing batch records
• Experience in initial hiring and training of new employees
• Operation of purification equipment, including chromatography skids and columns and ultrafiltration/diafiltration equipment
• Proficient in the use of UNICORN software
• Clean in place and Steam in Place of portable and fixed vessels
• Involved in changeover of equipment and start up of new projects
• Writing and Revision of standard operating procedures and batch records
• Led a shift of manufacturing professionals in successful campaigns for the manufacture of bulk API while meeting project deadlines and goals
• Interacted and communicated effectively with cross-functional teams (Quality Assurance, Technical Services and other support areas) in order to complete processing investigations for product release
• Involved in implementation of process validation protocols resulting in successful execution and approval of manufacturing processes From 1999 to 2002 (3 years)
bachelor of science, biology @ Fayetteville State University From 1995 to 1998 general @ Mott Community College From 1992 to 1993 Amy Ranta is skilled in: Purification, Manufacturing, Medical Devices, GMP, Sop, Validation, CAPA, Aseptic Processing, Change Control, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Part 11, V&V, Technology Transfer, Biotechnology, Change Management, Quality System, Cleaning Validation
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