Annaregina Roberts

Manager of Systems Validation August 2002 to present. Oversee all phases of the System Development Life Cycle (SDLC) of GLP regulated computerized systems.

2021-Present participated in the validation of electronic laboratory notebook software as a tester for functionality and Part 11 compliance, wrote and executed UAT scripts for validating the software.

Under the supervision of the Director of Laboratory Operations, coordinate and manage projects related to quality and compliance initiatives. Review Testing Facility quality operations to ensure that requirements are met, including SOP development, record keeping, and training. Assist in the preparation of client visits and response to client inspections. Evaluate, develop, and implement quality improvements for good record keeping. Provide guidance and training to technical staff with data review (electronic and paper record) procedure.

Under to supervision of the Director of Laboratory Operations, responsible for Management of the Quality Control program, including coordination of communications to the laboratory supervisors and the technical training group. Develop, manage and review core competencies for quality measures and milestones. Oversee the review of all raw data and technical functions required for submission of raw data for table preparation, assist technicians and research associates in all phases of data collection and finalization, give guidance and assist, when necessary, in answering internal/external audits, provide research associates with recommendations for technician review regarding technical skills, data recording, and management, identify training issues and assist in training technicians in proper GLP/SOP in protocol adherence.

Under the supervision of the Director of Laboratory Operations, supervise the laboratory staff; direct the coordination and documentation of training for all Laboratory personnel. Direct and coordinate revisions and review of SOPs. Responsible for assisting in the planning, direction, supervision and evaluation of animal reproductive toxicology safety studies on products and potential products.

Under the supervision of senior Quality Assurance staff, performed audits of protocols, raw data and final reports and performed inspections of laboratory operations and facilities.

Under the direction of senior Operations personnel, reviewed and analyzed all study audits, deviations and amendments. Identified common findings and developed methods to eliminate these finding from future studies. Served as a weekend Laboratory Supervisor.

Under the supervision of the Senior Scientist and Staff Veterinarian/Group Leader, Reproductive Toxicology, supervised the operations and technical staff of the Preparation Laboratory.

Supervised the dosing, observing, recording (computer and hand-recorded data), and tracking of the results of animal reproductive safety studies. Supervised the operations of the Chemistry and Rabbit Laboratories. Supervised and assisted in the training of the technical staff. Standardize procedures used in the 905 and 935 Test Facilities.

Dosed, observed, recorded and tracked the results of animal safety studies. Recorded data by hand or on a computer terminal. Kept records in order. Assisted with animal care when required. Assisted the Laboratory supervisor in supervision of the technical staff.

Performed data summarization and verification utilizing technically advanced data processing equipment.

Dosed, observed and recorded and tracked the results of animal safety studies. Recorded data by hand or computer entry. Kept records in order. Assisted with animal care when required.