Connie C. Email & Phone Number

San Francisco, Ca, Us

Nashville, Tennessee, Us

Nashville, Tennessee, Us

- Investigate deviations for the Facilities, EHS, and Engineering Department and determine if CAPAs are required- Initiate change controls to ensure changes to GMP equipment and GxP computerized systems are introduced in a controlled and coordinated manner- Collaborate with cross functional teams in investigations and support the execution of corrective actions- Collaborate with cross functional teams to support audit readiness for onsite audits (internal or regulatory) as required- Revise Standard Operating Procedures (SOPs) and work instructions for continuous improvement of documentation systems. - Review, track, and provide feedback on Facilities, EHS, and Engineering quality system records to ensure on time closure.- Supports the collection and maintenance of department metrics.

South San Francisco, California, Us

- Provide QA review and oversight of NCRs and assist and collaborate with cross functional teams in investigation and support the execution of corrective actions- Collaborate with the Lab Director(s) and QA Director to prepare out-of-state-license applications for Pennsylvania, Maryland, and New York for the CLIA laboratory- Oversee new and current suppliers to maintain and drive the accuracy of the Approved Supplier List.- Collaborate with cross functional teams to oversee equipment management to ensure new and current equipment were properly approved prior to use in all laboratories- Collaborate with cross functional teams to support audit readiness for onsite audits (internal or regulatory) as required.- Validates the quality of purchased materials based on set acceptance criteria with Incoming Quality Control- Writes, revises, and reviews standard operating procedures to ensure quality objectives are met- Maintains electronic and paper records for training and change control

Foster City, Ca, Us

- Manage aspects of the audit lifecycle: to include scheduling, planning, executing, issuing reports, requesting clarification, issuing observations and closing- Schedule pre-audit meetings with CMOs/CXOs to review audit agenda with the lead auditor and key stakeholders.- Incorporate sound risk management principles for the establishment of the annual audit schedule- Identify compliance risks and escalates issues to appropriate levels of management for resolution- Create, publish, and maintain metrics that measure the health and effectiveness of the audit program- Develop and report trends based on internal and external regulatory observations to better focus the scope of supplier audits- Create audit attestations and other documents as needed for mock FDA Inspections - Filgotinib and Lenacapavir- Manage and drive accuracy of the approved supplier list and ensure that the information for suppliers is accurate in GTrack/Trackwise system- Manage new audit requests and participate in due diligence assessments

San Francisco, California, Us

- Coordinate clinical trials to understand the use and behavior patterns of nicotine addiction, biomarkers of nicotine exposure, and how to prevent exposure of second-hand smoke in vulnerable populations for the Clinical Pharmacology Research Program- Manage databases, comprehensive datasets, and reports on REDCap- Obtain basic vitals from participants and collected urine samples to administer drug tests at screening visits- Facilitate daily clinical trial activities and served as the main point of contact with participants- Maintain participant confidentiality and complied with HIPAA guidelines while working with high PHI- Coordinate with nurses to create and edit Flowsheets and MD Orders to guide the study visits

Palo Alto, Ca, Us

- Worked as a Lead Health Improvement Program Health Screener for the Stanford Prevention and Research Center- Demonstrated proficiency in performing biometric assessments: blood pressure, height and weight measurements or the equivalent- Provided health screenings for over 7, 000 hospital employees of Stanford Health Care and Stanford Children’s health- Communicated frequently with the PM lead to co-supervise a team of eight health screeners- Maintained participant confidentiality, complied with HIPAA guidelines, and screened ~300 employees per day- Trained new hire employees to be proficient with CardioChek machines and assisted with module training

Columbia, Maryland, Us

- Worked as a wellness/immunization administrative assistant at Stanford Health Care in the Occupational Health Services department via Maxim Healthcare - Provided operational and clerical support in a wellness-and/or immunization-clinic setting to more than 7,000 employees- Assisted with high-volume clinic policies and procedures, setup and break-down of clinics, greeting clients and visitors, maintaining appointments, ensuring completion of paperwork, and data entry

Garden Grove, Ca, Us