Rita Mccullough Email & Phone Number

Boston, Ma, Us

-Provide Quality Oversite to cGMP Operations including: review and approve protocols, validations, investigations, CAPAs, procedures and change controls to assure compliance to all pertinent regulations-Provide guidance as an SME for: --Computer System Validation: GAMP5 software implementation/validations/external audits, primarily on CMMS Upgrade and Data Migration project, --Sterilization re-qualifications, --Equipment validations, --Maintenance programs and manufacturing operations-Prepare data compilation for product APQRs-Collaborate with other functional areas to gather and review investigation information and provide quality recommendations -Perform auditing functions for Quality on the Floor program and make quality recommendations-Represent Quality on cross-functional projects

Wilmington, Ma, Us

-Wrote test cases for use in creation of automated tests based on Agile user stories for Pharmaceutical DSCSA compliance for integration testing of cloud-based Pharmaceutical SaaS application-Ran custom automation tests, analyzed and documented results-Provided knowledge transfer to QA personnel

Wilmington, Ma, Us

-Managed QA testing of award-winning, audited cloud-based Pharmaceutical SaaS application providing solutions for complete global supply chain serialization traceability during the firm’s most explosive growth period due to regulatory final codification-Awarded TraceLink Customer Ownership Award, 2013-Collaborated with colleagues in Product Management, User Experience, Engineering, and Professional Services to provide customer-focused value in high quality product as evidenced by TraceLink being awarded: **CPhl Pharma Award for Best Innovation in Supply Chain & Logistic Management, 2015 **Deloitte Fast 500, 2015 **Amazon AWS Startup Challenge Winner for Business Applications, 2013 **Edison Awards - Health Management, 2013 **Supply & Demand Chain Executive 100 - Best Supply Chain Projects, 2013 **Red Herring Global 100, 2013-Led QA team’s adoption of Agile testing process via daily scrums and use of tools such as TestRail, Pivotal Tracker, JIRA, etc.-Wrote QA SOPs documenting the SDLC process-Wrote validation protocols for testing software tools-Hired and trained QA personnel in SDLC, customer use cases and product workflow

Wilmington, Ma, Us

-Collaborated with cross-functional teams contributing to TraceLink's success in being awarded: **Frost & Sullivan Entrepreneurial Company of the Year for Supply Network Collaboration Solutions, 2012 **Global Hot 100 Enterprises, 2012 **Silver Stevie Winner (International Business Awards), 2012 **Bronze Stevie Winner (American Business Awards), 2012 **Golden Bridge Awards, 2012 **Gartner Cool Vendor in Supply Chain Management, 2011-Created and executed testplans for cloud-based Pharmaceutical SaaS application-Administered and maintained cloud-based and local testing environments-Wrote custom xml property files for use in testing mapping software-Wrote shell scripts used in testing application-Wrote detailed instructions on configuration and maintenance on internal Wiki

Austin, Tx, Us

CMIT Solutions provided small to mid-sized organizations with affordable managed IT and QA engineering computer services. On delivering a technology assessment, we advised our clients on the strategic use of Information Technology to enhance security, increase productivity, and boost revenues. We offered several programs from full flat-rate managed services, providing unlimited helpdesk and onsite support, as well as, complete management of technology vendors, to as-needed support programs. We offered best-of-breed solutions to strategic issues including: disaster recovery, off-site data backup, intrusion prevention, software and hardware acquisition assistance, installation & upgrade maintenance, remote monitoring, WiFi, VoIP, intranets, webinars, website hosting, internet advertising, electronic newsletters and training.

Provo, Ut, Us

-Created and executed Configuration Testing testplan for Provisioning Application, Web Services Application Suite and SilverStream J2EE Application Server-Created and executed testplans for Feature Testing of Content Management, Security (LDAP, NT and SilverStream domains) and Expressions tool-Performed Installation Testing for Web Services Portal Application-Supported Testing Lab maintaining all UNIX platform upgrades (Solaris, SunOS, HP-UX, AIX, Red Hat and SUSE Linux) and all Database servers (Oracle, DB2, Informix, ASE, ASA, MS SQL, MySQL, Cloudscape)

Us

-Created and executed Configuration Testing testplan for Provisioning Application, Web Services Application Suite and SilverStream J2EE Application Server-Created and executed testplans for Feature Testing of Content Management, Security (LDAP, NT and SilverStream domains) and Expressions tool-Performed Installation Testing for Web Services Portal Application-Supported Testing Lab maintaining all UNIX platform upgrades (Solaris, SunOS, HP-UX, AIX, Red Hat and SUSE Linux) and all Database servers (Oracle, DB2, Informix, ASE, ASA, MS SQL, MySQL, Cloudscape)

Us

-As Software Council Fellow, wrote and executed testplans for telephony middleware application -Configured several PBX hardware platforms as needed for testplans -Performed backup customer support and website redesign activities

Sole proprietor of commissioned art business

-Successfully launched 38 products, including 12-component kits and monoclonal antibodies-Developed and maintained multi-million dollar budget with COGS of 35% -Created annual strategic plan for manufacturing, quality, shipping, supply chain-Created 5-year capacity plan (incremental cash flow requirements for equipment, space, personnel) relative to scale-up manufacture

-Directed manufacturing, QC, QA, materials control, shipping and interim customer service-Designed and managed buildout of new manufacturing, QC and QA facility, on-time and on-budget-Established and maintained cGMP compliance culminating in firm’s first FDA approval-Successfully launched 29 products, including 12-component kits and monoclonal antibodies-Developed and maintained multi-million dollar budget and COGS of 35%-Chaired MRPII software acquisition and implementation team-Awarded Commercial Contribution Award, 1991

-Reduced operating expenses significantly as the senior manager at facility, directing materials management, manufacturing, QC, shipping, maintenance and administration-Consolidated G&A, QC and warehouse operations from satellite facilities requiring FDA NDA approvals, negotiating leases and managing build-out of new corporate offices and labs culminating in zero inspection findings-Marketed and managed OEM services-Managed external CMO relations

-Directed generation of internal controls and documentation for FDA Drug Master File, as the senior manager at pharmaceutical manufacturing facility responsible for full regulatory compliance to GMP and NRC regulations -Directed manufacturing, QC, QA, materials management, shipping, maintenance and administration-Designed and built on-time, on-budget, state-of-the-art sterile pharmaceutical facility increasing capacity 4-fold-Secured IRB financing at 75% of prime for newly capitalized facility-Served as Radiation Safety Officer, liaison to consultants, FDA and NRC, culminating in zero inspection findings-Served as lyophilization SME in scale-up of several product cycles

-Managed final product release of 10 small volume parenteral (sterile, injectable) diagnostic products, maintained all documentation, investigated customer complaints, led self-audit committee-Served as Radiation Safety Officer, liaison to consultants, FDA and NRC-Recommended and performed studies and submitted for successful update to a USP monograph-Trained personnel in cGMP

Continuing Ed In Pharmaceutical And Computer Sciences

B.S., Biological Sciences