Carol Black Email and Phone Number

Ensures compliance with cGMP regulations and company procedures for drug product manufacture (injectable dosage forms) by reviewing/assessing documentation associated with investigational medicinal products. Review and approve documents related to Quality Systems such as master batch records, executed in house and vendor batch records, procedural documents and other documentation as needed. Participates in investigations into deviations and review/approve investigation reports and CAPAs. Conduct internal audits and contractor audits as needed. Provides guidance on GMP issues, interpretation of regulations and maintain awareness of regulatory trends and industry practices.Quality Lead for the Microbiology testing laboratory, mentor junior lab team member and Rutgers studentsQA project lead for implementation of audit management tool (ACE Inspection)

Manages specification and methods for all BMS commercial productsGlobal Testing Standard SME for a change control related specifications in TrackwiseServe as a guest auditor upon request from the Global Internal Audit teamServe as back room support during FDA general inspections Provided Health Authority support during the Devens FDA inspectionPreapproval Inspection (PAI) readiness for the following BMS sites Devens, Manati, AnagniManages periodic review of Directives and PoliciesAuthored SOPs and Work instructions for all Global Testing Standards related proceduresInteract with various cross functional groups such as Regulatory CMC, MS&T, Change Control, Global Analytical TechnologyQA representative for all Global Analytical Technology documents in documentation management system (DCA) Managed the integration of Amylin specifications and method into company specification database

Project Management Experience·Assisted with the validation team that successfully validated viable air monitoring equipment SMA One Touch Control System. Contributed to numerous project plans and tracked projects, which allowed for timely completion for the installation of a new M & O Perry Filling machine.·Managed two large scale projects; one which successfully validated several laboratory and facilities/utilities; one which brought into compliance the environmental monitoring program for the manufacturing dept.; and onebrought into compliance a new quality control microbiology laboratory which had zero observation during FDAinspection.Laboratory Systems & Equipment Validation ExperiencePrepared PQ protocols for bioburden, microbial limits and bacterial endotoxin testing of actives and excipients. ·Created SOPS for laboratory equipments such as multi-block dry bath, incubators, refrigerator, biosafety cabinets. ···

Supervised and trained personnel in the microbiological & monitoring testing laboratories on FDA registered vaccine product and assured testing conformed to company SOPs, USP/EP/JP regulationsManaged Microbiologists and Supervisors annual performance review and development plans Performed data review in LACES LIMS and investigation review TrackWiseInitiated/reviewed Change Controls, served as a Change Control Committee memberDepartment representative for new state of the art QC Microbiology laboratoryReviewed and approved validation protocols and reportsInteracted with internal and corporate compliance auditors during inspectionsEffectively managed testing of various over the counter products, and the USP Vitamin B12 & Biotin assay. The Environmental-Monitoring Laboratory performed viable and nonviable particulate monitoring of vaccine filling line Supervised the method validation personnel in laboratory testing assuring that test methodvalidations are executed according to approved protocols and industry standards The Validation Laboratory performed Sterility Validation, Bioburden Validation, Microbial Limits Validation, Cleaning Validation, Vitamin B12 & Biotin method validation, and autoclaves re- qualificationsDeveloped test method validation protocols, reports, User Requirements Specification, Validation Master PlanProject lead for the start-up of new state of the art microbiology laboratory which includes the installation of three transfer isolators, Vitek compact identification system, Milliflex membrane filtration system

Internship position preparing media, Identification preparation, water sampling, and equipment monitoringProgressed to additional responsibilities and roles as Scientist I, II, III, and Group Leader Performed various microbiological analysis such as environmental monitoring, sterility testing, bacterialendotoxin, antimicrobial effectiveness testing, microbial limits testing, water testing, identificationSupervised and trained personnel in laboratory testing while being responsible for assuring testing conformed to company SOPs, and USP and FDA regulations Oversee QC Microbiology Laboratory activities such as sterility and microbial limits testing of water, raw materials, components and finished products, antimicrobial preservative effectiveness, environmental monitoring of Aseptic facility, bacterial endotoxin and validation testingReviewed and release microbiological evaluation for compliance including: sterility testing, bacterial endotoxin testing (gel clot) antimicrobial effectiveness testing of finished products, microbial limits, Successfully transferred all microbiological test method to various outside testing laboratories ensuring that each method transfer was in compliance with approved protocols Project lead for the decommissioning of the QC Microbiology and In Process laboratory during company closure