Consultant, Kevin Kennedy Associates Inc.
Providing expertise in biochemistry, quality assurance, validation, manufacturing and packaging, QA cGMP compliance, pharmaceutical and medical device technical management, and related expertise to a wide variety of clients.
Sr. QA Consultant, The Medicines Company, Waltham MA and Parsippany NJ
Prepared the annual product review for a anti-thrombin drug; wrote the executive summary for presentation to the executive management group. Assessed and prepared recommendations for improvements in the SOPs in the Manufacturing Group. Was responsible for the Manufacturing/QA Product Complaint system; developed new SOPs; Chaired the Product Complaint committee. Reviewed and corrected Master Production Records from CMOs, Process Validation and API Validation protocols, clinical and commercial API batch records, and clinical and commercial productions for product release.
Sr. QA Consultant, Acambis, Cambridge MA
Was responsible for vaccine data and technical report review (Title 21 CFR §58, 210 and 211). Audited clinical toxicology studies on mice and monkeys in accordance with Title 21 CFR §58. Audited Research and Development notebooks; the data from which was used in technical documents (Title 21 CFR §58 and 211). Audited and reviewed technical documents for a new vaccine (transgenetic chimeric virus); the documents were use to support the BLA submission.
Consultant, Parexel Consulting
Prepared qualification guidance documents for a Korean biotechnology facility, e.g., Generation of WFI, Generation of Clean Steam, Technical Guidance for Depyrogeneration Ovens, Technical Guidance for Lyophilizator, etc. Prepared IQ/OQ protocols for deionized water system(s). Prepared IQ/OQ protocols for process and ancillary manufacturing equipment, e.g., blenders, tablet presses, mixers, tablet dedusters, coating systems, etc.
Consultant, MediSense, Bedford MA
Was responsible for medical device validation/equipment qualification (Title 21 CFR §820 and ISO13485). Prepared and executed IQ/OQ protocols for manufacturing equipment. Prepared SOPs for manufacturing equipment use and cleaning.
Consultant, Bio-Reg Associates, Inc., Beltsville MD
Provided expertise in Quality Assurance for a Medical Device/IVD company under consent decree (Title 21 CFR §820 and ISO13485). Evaluated the SOPs used to establish the Design History Files (DHF). Investigated data/information in DHF and the design controls, document controls, purchasing controls, process validation, etc. Mentored the Subject Material Experts (SMEs) in responding to potential questions by FDA investigators.
Quality Assurance Consultant, Pure encapsulations®, Sudbury, MA
Was responsible for Quality Assurance dietary food supplements (GMPs are not approved; used Title 21 CFR § 100, 211, and 820). Prepared over 100 standard operating procedures for setup, operation, and cleaning of manufacturing equipment, receiving raw materials, sampling raw materials, shipping finished goods, warehouse operation of FIFO, calibration of equipment, etc. Prepared corporate SOP for customer complaint system. Prepared master and production/packaging batch record templates.
Quality Assurance Consultant, Sepracor, Inc., Marlborough, MA
Provided expertise in Quality Assurance and Validation (Title 21 CFR § 58, 210, and 211). Performed cGMP audits at outsourced facilities (CMO's). Reviewed API master and executed manufacturing records (ICH Q7A Guidance); resolved analytical OOS reports. Reviewed executed manufacturing, packaging, and stability batch records from CMO's for clinical materials. Reviewed analytical results for release of: raw materials, packaging components, and finished product; resolved OOS/OOT reports. Reviewed executed commercial BFS manufacturing, packaging, statistical process control records; reviewed the associated analytical results and resolved any OOS. Reviewed process validation protocols, qualification protocols, and technology transfer documents for sterile facility. Reviewed validation summary and IQ/OQ/PQ summary reports. Worked with R&D to resolve process difficulties on a new controlled release product.
Manager, Quality and Scientific Affairs, SciVolutions™, Inc., Stoughton, MA
Worked with the local and small business main district FDA to bring a series of Class I medical device products into the United States. Prepared and executed the finished product sterility validation. Prepared all quarterly gamma radiation protocols and samples for testing. Established the customer complaint procedure. Prepared Standard Operating Procedures (Title 21 CFR §820).
Manager, QA/QC, NutraMax Products, Inc., Cough and Cold Division, Brockton, MA
Was responsible for total divisional quality affairs (Title 21 CFR §210 and 211). Quality team that directly interfaced with the FDA for all inspections as well as third party inspections. Responsible for maintaining a kosher facility; Interfaced directly with the Rabbi's for their quarterly inspections. Reviewed manufacturing and packaging batch records along with the SPC charts. Developed and implemented manager's quality awareness program. Developed and implemented compliance and customer complaint trending systems that alerted management to potential problem areas. Reviewed and approved manufacturing/packaging SPC charts, data, and production records for product release. Developed and implemented a cGMP training program for the packaging and production staff. Staffed and trained the quality control department in accordance with cGMP (Title 21 CFR §210 and 211) and GLP (non-clinical, Title 21 CFR §58). Implemented analytical method validation and reviewed summary reports. Prepared and implemented the divisional Out of Specification SOP in accordance with the FDA Guidance. Established all packaging component, raw material, and literature specifications.
