Mary Jo Bock Email and Phone Number

Collaborate with Global key stakeholders to develop QMS process strategies, lead QMS process development and implementation, and provide QMS process training and consultancy to division. Business Process Owner for CAPA and Risk Management. Use analytics to drive Continuous Improvement projects (data trends, observed gaps, and business workflow changes). Familiar using SharePoint, JIRA, Agile Project Management software, Success Factors LMS and SBM databases for documentation.

Election Clerk / Majority Judge - duties include set up and tear down of electronic poll books, voting machines, supplies and room layout; in a professional and respectful manner, check in registered voters, assist voters in using the voting machines, crowd control, and collaborate on decisions and troubleshooting.

• Manages all aspects of the ISO 9001:2008 QMS and certification, and successfully developed and implemented a plan to transition the site to ISO 9001:2015• Developed an ISO 17025 QMS and successfully drove the site accreditation from 2012 to present• Drive cross-functional site internal audit program, by preparing the quarterly audit plan, directing the site auditor team, scheduling audits, developing and reporting CAPA, and corrective action tracking. • Develop, implement, and maintain local and global controlled documents system such as SOPs, PSM procedures, and test methods.• Liaise with IT server administrator to ensure appropriate access to documents, records, electronic notebooks (ELN), APQP databases and research reports.• Drive risk assessment and continuous improvement programs to completion.• Oversee the Contract/External Provider management program, including performance. • Deliver QMS status, trends, COPQ, RCFA results and critical KPIs during Quarterly Management Review meetings, and to staff.• Oversee site Calibration Program including non-conformance reports.• Coordinate external certification audits and participate in customer visits and supplier audit meetings. • Adviser to three manufacturing sites on their compliance programs, providing 2nd party audits as requested.• Deliver site quality and safety opportunities, including new employee orientation, competency and proficiency evaluations, and refresher training. Coordinate special opportunity training like internal auditor or hands-on technique training. • Working knowledge of IATF 16949, AS9100, and GxP requirements, by collaborating with manufacturing sites on best practice assessments, supplier audits and incident investigations.• Developed a Quality-driven climate on site, by emphasizing the quality of products over obtaining a certificate.• Proficiency in enterprise systems to track activities, including EtQ, SFDC, iNexus, and SharePoint.

• Prepare complex formulations of polymers for physical and chemical testing.• Performed a broad variety of tests on liquid and solid samples to test for failure and performance while comparing to commercially available products.• Record and track complex experimental data using electronic notebooks and Microsoft office software.• Monitor and track inventory of critical materials, and ship hazardous materials to other sites.• Perform calibrations and procedures as required by ISO9001:2008 guidelines, SOP's and test methods.• Apply new formulations of paints using manual methods, as well as gravity spray guns, to prepare samples for property testing.• Performed internal audits of staff and laboratories, and documented findings in an effort to improve and progress the department’s Quality Policy adherence.• Assist other investigators in their projects, and coordinate work responsibility with them and the PI's.

• Performed sample preparation, method development, quantitative bioanalysis using LC-MS/MS, and wrote summary reports for customers (project teams).• Lead cross-functional project to create lean procedures for uploading data to databases and reporting information back to project teams in a timely fashion. • Wrote SOPs, training documents, database protocols, and robotic programs.• Coordinated department analytical resources between requestors, customers and staff, including CRO work.• Tackled difficult compounds by using new technology to develop innovative methods quickly• Documented studies in accordance with GLP/GLS requirements in a timely fashion, including electronic notebook software

• Performed sample preparation, method development of NCE’s (new chemical entities), and quantitative bioanalysis using HPLC-UV and LC-MS/MS• Maintained laboratory and studyfiles according to GLP, and well as Animal Care and Use Procedures and importation permits, according to AAALAC and USDA.• Planned in vivo experiments to determine pharmacokinetic and ADME parameters• Interact cross-departmentally to coordinate studies in support of project teams. • Designed, programed, and implemented robotic methods on a TECAN Genesis instrument for DMPK department use. • Established studyfile templates for DMPK department, to increase our efficiency.

• Performed sample preparation, method development of NCE’s (new chemical entities), and quantitative bioanalysis biological matrices such as plasma, tissues, and excreta using HPLC-UV.• Maintained and repaired laboratory equipement• Planned in vivo experiment analysis, equipment, supplies, and animal resources• Maintained laboratory and studyfiles, as well as wrote reports, according to GLP• Developed and implemented new technology procedures and In vitro techniques (liver fractions), and transferred them to business groups where they impacted projects.

• Performed sample preparation, validated bioanalysis in complex biological matrices using GC-LLE methods, and uploaded data to LIMS• Developed solid phase extraction methods of drug metabolites using GC with NPD, MS detectors and liquid scintillation counting for C14. • Maintained laboratory and studyfiles according to Good Laboratory Practices (GLP), safety and departmental standards. • Prepared and audited tables, figures and summaries for internal reports and a New Drug Application (NDA).

• Measured the biodegradability of compounds by performing HPLC and CO2 analysis of compound solutions spiked with environmental microbial cultures.• Performed toxicity tests including Microtox, Daphnia IQ test, and the FDA Microbial Inhibition Test and bioassays, such as protein and ATP assays.• Prepared and assembled documentation for Environmental Assessments (EA’s) of New Drug Applications (NDAs) for the FDA. • Wrote and revised Standard Operating Procedures, and maintained laboratory according to Good Laboratory Practices (GLP).

• Isolated and performed growth curves and identification tests on bacterial cultures from mixed environmental populations.• Conducted toxicity tests using microbial cultures in the presence of test substances.• Instructed new employees while demonstrating common laboratory procedures.