Change Control for Automation Department

Batch record review and certification for Johnson & Johnson Covid vaccine.

Equipment and Facilities qualifications for CAR-T CMO manufacturing and facility re-certification.

Consent Decree Remediation. Re-start preparation, deviation investigations, execution of data Integrity in quality control laboratory.

Conduct Change Control risk assessment and remediation.

Workstream lead for the Product Process Validation remediation efforts. Shipping Validation compliance guidance for both refrigerated and room temperature products. Computer Software Validation (CSV) and compliance for MasterControl and ASCTrac.

Provided 3rd party QC laboratory witnessing activities to verify use of appropriate methods and techniques to ensure contemporaneous recording and integrity of associated data in accordance to approved testing methods, laboratory controls, standard procedures and applicable protocols.Conducted CAPA / Deviation investigations on site utilities.

Warning letter remediation effort for production and process controls; aseptic processing practices; and quality system with a focus on deviation and CAPA systems. Batch Records review and certification.

Commissioning and validation of commercial biological manufacturing facility expansion for successful PAI.

CAPA remediation efforts and response to Health Canada audit observations.

QSR assessment of Data Integrity and Data Reliability to support final product disposition.

Validation SME to provide support for facility expansion project for the validation of FUE systems such as HVAC, water systems, compressed gases, manufacturing equipment, computer systems and processes.

Performed gap assessments on the following Quality Management Systems (QMS); Nonconformance/CAPA, Production and process Controls including technical transfer and validation, Facility and Equipment Controls, Materials Management Controls, Change Controls including documentation systems, training systems, laboratory systems, Information Management, and Purchasing Controls and Supplier Management.

Observed end to end batch processing; provided feedback on adherence to procedures to improve employee performance and raise cGMP compliance and awareness.Provide one-on-one mentoring for manufacturing personnel including: directors, managers, supervisors, lead technicians, and operators.Critical Response Team (CRT) member which addresses 483 audit observations for preventative maintenance issues.

Provide oversight in the execution of daily GMP cleaning and sanitization tasks performed by contract personnel in sterile injection manufacturing. Provide guidance and mentoring, as needed, to ensure cleaning personnel perform the tasks required in a complete and accurate manner.

Develop Cleaning Master Validation (CMV) Plan and design cleaning strategies for Active Pharmaceutical Ingredient (API) manufacturing for multiple product families produced in both dedicated and non-dedicated process trains.

Review imaging records from healthcare IT service events for compliance and consistency, track/address trends observed that could lead to non-compliance or risk to patient/user safety under 21CFR Part 803 (MDR).

Developed the Master Validation Plan (MVP) for the overall qualification / validations of utilities in support of expansion within a three building complex.

Provided Computer Software Validation (CSV) support with approval responsibilities for the both equipment and systems validation in the area of Software Quality Assurance (SQA), Software Development Life Cycle (SDLC) and software applications used in the manufacture of self expanding and balloon expanding stents.Provided solutions necessary to meet business and regulatory requirements within GMP, 21 CFR Part 11 and 21 CFR Part 820. Provide approved quality project deliverables including; Master Validation Plans (MVP), FMEA, URS, FS, RTM, IQ & OQ test procedures and reports, Final Validation Reports, Corrective and Preventive Action (CAPA) processes and Change Control documentation for projects.

Evaluated and summarized validation efforts for plant CE (Conformité Européenne) recertification.Developed Master Validation Plan Initiative for legacy processes and equipment.

Developed IQ/OQ/PV protocols for an Automated Microparticle Processing System (AMPS) which produces paramagnetic protein coat particles utilized by Abbott'ss Architect system.Established user, functional and design specifications to support redesign of AMPS equipment, software and database.

Developed and executed IQ/OQ/PQ Common Process validation protocols for viral/complement protein heat inactivation and mixing processes.Equipment, process and controls qualification experience with tanks, utility systems, autoclaves, mixers, pumps, ovens, dryers, refrigerators, coolers, freezers, incubators, batch reactors/bioreactors, water baths, decontamination systems, I/O verification, Cleaning-In-Place (CIP) and Steam-In-Place (SIP) systems. Extensive knowledge of thermal mapping and experience with data tracers and Kaye Validator instruments.

Developed and executed IQ/OQ Computer Validation protocols for PLC upgrade of autoclave PLC’s.

Developed and executed IQ/OQ validation protocols for the manufacture of HIV Rapid Diagnostic Test strips and supporting equipment and utilities.

Conducted autoclave validation with temperature mapping studies. Developed and executed IQ/OQ/CV validation on HVAC units equipment with Johnson Controls system.Developed and executed IQ/OQ protocols and SOPs for Quality Control Laboratory instrumentation.

Developed and executed IQ/OQ/PQ validation protocols for tablet manufacturing process.Developed and executed IQ/OQ/PQ validation protocols for tablet packaging equipment including bottle and blister pack lines.Developed and executed Computer Validation protocols for analytical instruments (TGA/DSC; FTIR).

Developed and executed IQ/OQ/PQ validation protocols for tablet filling and blister pack packaging lines in support of new product launch.

IQ/OQ/PQ development and execution for Blow/Fill/Seal (B/F/S) systems and production equipment.

Developed and executed IQ/OQ/PQ validation protocols in support of the manufacturing of a sterile biological. Validation of utilities and facilities.

Generic Drug Development

Sterile Injectables Manufacturing

Research and Development Chemist

Microbiology, Clinical Chemistry, Pathology, Hematology, Parasitology