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Rita Mccullough is a SQA Engineer and Manager | Pharmaceutical Manufacturing Management at Biotech. She possess expertise in quality assurance, regulatory compliance, pharmaceutical industry, medical diagnostics, supply chain and 22 more skills. Colleagues describe her as "Independent and thorough are the words that come to mind when I try to describe Rita's work for me at SilverStream and Novell. Our QA team needed to test many versions of our software, on a number of Unix platforms, against a variety of back-end databases. Along with other testing responsibilities, Rita specialized in organizing and documenting the multi-configuration aspect of our work. She also kept much of this software working and up to date, making it much more efficient for others to do their jobs. It's always great to have someone who just figures out what needs to get done and does it, while needing little to no direction. She's a pleasure to work with and I wouldn't hesitate to work with her again.", "I worked closely with Rita from the beginning days of TraceLink, from 20 people to todays almost 200. I found her leadership, technical expertise and product knowledge to be exemplary. She took ownership of a problem through to completion and led by example. She has an in depth understanding of the specific needs of the pharmaceutical industry and ensured that the work in her group always exceeded that extra attention to detail. I look forward to the opportunity to work with Rita again.", and "Rita and I worked closely together during the very early startup stages of Tracelink. The timelines were short, the expectations were high. Rita repeatedly demonstrated the ability to pitch in and get the job done. She is meticulous and methodical. Part of Tracelink's success is due to Rita's extensive experience and dedication. I look forward to working with her again."
Biotech
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Principal Quality AssuranceBiotech Jul 2021 - Present
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Senior Quality EngineerPharmaceutical Aug 2016 - Jul 2021-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
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Sr Qa EngineerTracelink Feb 2015 - Apr 2016Wilmington, 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 -
Qa ManagerTracelink Jan 2013 - Jan 2015Wilmington, 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
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Sr Qa AnalystTracelink Dec 2010 - Dec 2012Wilmington, 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
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PresidentCmit Solutions Of Metro Northwest Apr 2006 - Dec 2010Austin, Tx, UsCMIT 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. -
Qa EngineerNovell, Inc 2002 - Nov 2005Provo, 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) -
Qa EngineerSilverstream Software 1998 - 2002Us-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) -
Qa EngineerAurora Systems 1997 - 1998Us-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 -
OwnerMccullough Studios 1993 - 1996Sole proprietor of commissioned art business
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Vp, OperationsT Cell Diagnostics, Inc 1991 - 1993-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
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Director, OperationsT Cell Sciences, Inc 1988 - 1991-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
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Director, ManufacturingCis-Us, Inc 1985 - 1988-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
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Plant ManagerSyncor International Corp 1980 - 1985-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
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Qc ManagerCis Radiopharmaceuticals, Inc 1975 - 1979-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
Rita Mccullough Skills
Rita Mccullough Education Details
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Harvard Univ, Umass, Parenteral Drug Assoc, Ctr For Prof Advancement, Software Council Fellowship PrContinuing Ed In Pharmaceutical And Computer Sciences -
University Of Illinois Urbana-ChampaignBiological Sciences
Frequently Asked Questions about Rita Mccullough
What company does Rita Mccullough work for?
Rita Mccullough works for Biotech
What is Rita Mccullough's role at the current company?
Rita Mccullough's current role is SQA Engineer and Manager | Pharmaceutical Manufacturing Management.
What is Rita Mccullough's email address?
Rita Mccullough's email address is ri****@****ink.com
What is Rita Mccullough's direct phone number?
Rita Mccullough's direct phone number is +160357*****
What schools did Rita Mccullough attend?
Rita Mccullough attended Harvard Univ, Umass, Parenteral Drug Assoc, Ctr For Prof Advancement, Software Council Fellowship Pr, University Of Illinois Urbana-Champaign.
What are some of Rita Mccullough's interests?
Rita Mccullough has interest in Gardening, Hiking, Cross Country Skiing, Completed All 48 Nh 4000 Footers, Ethical Development, Healthy Lifestyle.
What skills is Rita Mccullough known for?
Rita Mccullough has skills like Quality Assurance, Regulatory Compliance, Pharmaceutical Industry, Medical Diagnostics, Supply Chain, Program Management, Cloud Computing, Enterprise Software, Unix Administration, Database Administration, Data Analysis, Saas.
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