Experience

Genus Lifesciences Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Jul 2021 - Present

• Associate Manager

  • Mar 2015 - Present

  Quality Auditor and Project Specialist • Provides direct support to QA Management in everyday operations of the QA Department• Develop employees through feedback on job performance and on the job training • Perform on the job training and awareness training to manufacturing and packaging personnel • Perform cGMP training for new hires• Organize and execute investigations into quality issues as they relate to manufacturing, packaging, packing materials, labeling, in-process materials and finished products. Investigations into complaints. • CAPA Management to ensure root causes are eliminated through assigned CAPA tasks• Create and execute Change Control and assessments of changes pertaining to SOP creation and updates to procedures. • External quality audits of contract laboratories • Protocol and Report execution for Clean/Hold Time Studies of manufacturing equipment• Assist with daily operations of manufacturing and packaging including equipment, room and packaging operations room release. • Manufacturing and Packaging Batch Record review and approval• Interface with customers and field inquiries on batch records and investigations



McNeil Consumer Healthcare

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Quality Assurance Microbiologist

  • 2013 - Dec 2014

  Participation in implementation and sustainability of requirements for the Consent Decree to functional areas • Identification of gaps in processes at the various microbiological laboratories within the network and development of methods to standardize laboratory practices while under Consent Decree • Standard Operation Procedure writing at network level to standardize practices across multiple microbiology laboratories • Provide microbiological expertise as subject matter expert on various committees such as Product Specification, Change Control, Compendial Updates and Product teams. • Review of technical documents such as method validation protocols and reports per USP Chapters <61> and <62> Change Control author and coordinator • Review of Objectionable Microorganism Assessments • Raw Material Testing Assessment writing for External Manufactures and across the sites • Contract Manufacturing Facility Audit (For Cause) as Subject Matter Expert (SME)



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientific Supervisor

  • Apr 2008 - Oct 2013

  Supervise a staff of scientists and technicians in a cGMP Microbiology QC•Attained professional coach certification as well as receiving training in facilitation, team management, problem solving/decision making and lean initiatives•Responsible for project management applications as required for the laboratory•Hiring/interviewing of prospective candidates•Experience with numerous FDA Inspections•Oversight of analyst training and development including conducting performance reviews and establishment of goals•Writing and/or reviewing of standard operating procedures (SOP’s) for the laboratory•Conduct internal and external quality audits at contract laboratories and vendors•Review and Approval of all test documentation through the utilization of the LIMS system•Conduct Laboratory Investigations including implementation of corrective and preventative actions•Method development and suitability of microbiological test methods for R & D products as per USP <61>, and <62>•Facilitation of laboratory meetings as well as team member for planning, release, transfer, and R&D product teams•Interfaced between various departments such as Process Engineering, Validation, R&D, QA, RA, Planning and Manufacturing •Determination of Significance of Isolated Organisms from Finished Products, Raw Materials, •Experience with performing, reviewing, training on the following types of testing: water, environmental monitoring (air and compressed gas testing), pharmaceutical finished products, raw materials, API’s, packaging components, organism identifications using biochemical tests, VITEK, and strips, cryopreservation, growth promotion testing, Antimicrobial Effectiveness Testing (AME/AET) and validation, coating samples, sanitization swabs•Rapid Microbial Test Method establishment and selection of BactiFlow•Establishment of alert/action levels for water and air monitoring•Equipment Maintenance and Calibration•OSHA 40 hour certification

• Scientist

  • Apr 2002 - Apr 2008

  •Oversight of analyst training and development including conducting performance reviews and establishment of goals•Writing and/or reviewing of standard operating procedures (SOP’s) for the laboratory•Conduct internal and external quality audits at contract laboratories and vendors•Method development and validation of microbiological test methods for R & D products• Team member for planning, release, transfer, and R&D product teams• Interfaced between various departments such as Process Engineering, Validation, R&D, QA, RA, Planning and Manufacturing •Experience with performing, reviewing, training on the following types of testing: water, environmental monitoring (air and compressed gas testing), pharmaceutical finished products, raw materials, API’s, packaging components, organism identifications using biochemical tests, VITEK, and strips, cryopreservation, growth promotion testing, Antimicrobial Effectiveness Testing (AME/AET) and validation, coating samples, sanitization swabs•Rapid Microbial Test Method establishment and selection of BactiFlow•Equipment Maintenance and Calibration•OSHA 40 hour certification