PAREXEL INTERNATIONAL, Billerica, MA (Decentralized in Montana) 2013 – 2020
Provided subject-matter expertise to mentor and troubleshoot for many national and international confidential clients. Interfaced with diverse personnel from the analyst-level to personnel at the highest levels of quality organizations. Delivered professional knowledge for projects performed under attorney-client privilege.
- Expert in writing deviations, investigations, and batch record reviews for the purpose of certifying commercial product for release.
- Provided support for process improvements and observation remediation in the area of QC.
- Improved the quality and thoroughness of deviations and investigations through review, certification, and mentoring of client’s deviation writers in order to guarantee thoroughness in response to FDA 483 observations.
- Drafted FDA 483 and warning letter remediation and response.
- Conducted sterility assurance, aseptic process, contamination control, and microbiological assessments and audits, including the review of media fills, environmental monitoring programs, aseptic process controls, and qualifications.
- Led microbiology and batch record review, data integrity assessment, and auditing.
- Performed quality system evaluation in CAPA, OOS, and deviations.
- Managed data integrity.
OXFORD CONSULTING/PAREXEL INTERNATIONAL REVIEW, City, ST 2012 – 2013
Third-Party Batch Record Review
Served as a subcontractor consultant to a large injectable pharmaceutical manufacturing facility to conduct batch record reviews. Recruited to join Parexel full-time.
- Subject-matter expert (SME) support for review of microbiological and quality documents in support of third-party batch record review.
- Delivered subject-matter expertise for batch record review in order to provide third-party support to recommend disposition of products.
INTEGRA LIFE SCIENCES, Plainsboro, NJ 2011 – 2012
Supervised and managed microbiology department with seven direct reports.
- Conducted investigations for microbiological and production-related issues.
- Led audits and provided subject-matter expertise and support on external audits.
- Provided subject-matter support and expertise in cross-functional teams related to environmental and sanitization practices, improving overall microbiological quality to manufacturing processes.
- Qualified a new ISO 5 -8 manufacturing facility.
- Led and directed initiative to successfully validate legacy endotoxin test method procedures.
VALIDANT CONSULTING, City, ST 2010 – 2011
Conducted investigations for a major injectable pharmaceutical manufacturing facility in the Midwestern U.S.
- Successfully reduced backlog of environmental and microbiological exceptions (deviations).
- Provided support and aptitude for contract-manufacturing clients in resolving microbiological issues.
ENZON PHARMACEUTICALS, South Plainfield, NJ 2005 – 2009
Microbiology Manager and Consultant
Recruited in 2005 to improve productivity and quality. Microbiology manager for a six-to-seven-analyst, quality control laboratory that ensured microbiological quality attributes for finished products, production environment, and raw materials. Played key role in helping firm achieve validation for ISO 5, class 100 facility classifications. Stayed onboard through facility closure in 2008 to assist in the relocation of key processes to Indiana facility. Recruited back to R&D facility in 2008 as a consultant to successfully implement an environmental monitoring program for ISO 5 – 8 classified filling areas. Authored a comprehensive white paper laying out the strategic roadmap for environmental monitoring (EM) program. Took the lead in implementing the EM program, culminating in successful validation for use of classified areas.
- Reduced production downtime with new water-testing protocols. Water purity testing at Enzon contained errors and inconsistencies. Designed and implemented procedures and streamlined SOPs with simplified documentation, fewer steps, and less test media. Retrained staff and significantly reduced errors and need for retesting, cutting downtime.
- Cut data collection and test method error rate 50%. Created validated and streamlined procedures and processes and implemented new cross-training and reorganization of staff. Reduced CAPA reports from 70 to 35 annually.
- Successfully developed an environmental monitoring program suitable for classified areas in a process development laboratory for clinical phase I work.
- Provided expertise and testing support for media simulations in filling operations; enabled controlled area use for the aseptic filling of investigational products.
- Developed strategies through the use of the CAPA system, investigational writing and other practices to troubleshoot and improve processes in the microbiology area.
- Developed an environmental monitoring program to validate new, classified manufacturing areas (ISO class 5 to class 8).
- Delivered subject-matter support for FDA and European inspections and interacted with agencies during inspections.
- Provided subject-matter and quality control expertise during external audits.
- Supplied microbiological expertise to support R&D projects and interact with domestic and international companies for new projects.
- Extensively validated and troubleshot issues for the microbiological control of water systems.
- Conducted SOP revision and development.
- Led and authored investigations and CAPAs associated with microbiological issues and microbiological issues related to manufacturing issues.
AEROTECH P&K, Cherry Hill, NJ 2004 – 2005
Quality Assurance Specialist
Performed extensive work in implementing a quality system compliant with ISO 17025 requirements, collaborating with superior in a sister laboratory in Arizona and with the local laboratory director. Played key role in fast tracking ISO certification at Aerotech. The firm needed to quickly win ISO certification in order to build business as an expert witness in litigations. Reviewed, revised, and documented more than 60 SOPs, setting stage for firm to win crucial ISO17025 certification.
- Implementation of quality system pursuant to ISO 17025 requirements.
- Responsibilities included: approving, adopting, writing, revising, and implementing quality system documents and standard operating procedures.
- Experience in using laboratory information management system (LIMS).
- Worked independently as the only quality assurance specialist on staff, with supervision located at sister facility in Phoenix, AZ.
- Responsible for all QA functions and systems at the facility.
- Responsible for quality system, quality assurance orientation, and corporate ethics training.
- Served as the quality system interface with various regulatory agencies (AIHA, NJDEP).
FRESENIUS MEDICAL CARE, Delran, NJ 1996 – 2004
QC Microbiology Supervisor
Hired as a bench microbiologist in 1996 and was promoted to supervisor of the microbiology laboratory in 1997. Performed extensive work in method development, writing, and validation. Responsible for ensuring adherence to all applicable FDA, AAMI, and USP guidelines. Remained onboard through facility closure in 2004 to assist in relocation of key processes to Ohio facility.
- Developed an innovative, low-cost decontamination process. The process under consideration at Fresenius (using nitrogen gas for drying post CIP process) was costly and inefficient. Developed and proved the efficacy of the alternative process using low-cost UV lamps for bioburden control. Implemented process improved quality and produced significant cost savings.
- Led the development and/or validation (IQ, OQ, and PQ) of several bacterial endotoxin test (LAL) methods, including gel clot, kinetic turbidimetric, and kinetic chromogenic techniques.
- Performed method validations and revisions of SOPs for bioburden-type tests.
- Developed out of specification (OOS) investigation procedures for microbiological assays.
- Created an environmental monitoring program to develop investigational procedures for environmental excursions.
- Provided subject-matter interaction and presence with FDA during inspections.
- Interacted extensively to troubleshoot issues for the microbiological control of water systems.
- Developed training sessions for aseptic handling and sampling techniques for production personnel.
- Engaged with personnel across the U.S. to develop microbiological policy and problem solve.
- Bacterial endotoxin testing of water, raw material, and finished product using LAL gel clot and kinetic methods.
- Performed surface and air environmental monitoring in controlled production areas.
- Conducted external and internal quality audits.
Contract Roles for Johnson & Johnson, Whitehall-Robbins, and Ethicon.
EDUCATION AND PROFESSIONAL DEVELOPMENT
Bachelor of Arts, Microbiology, RUTGER’S UNIVERSITY, New Brunswick, NJ