Whitney First Email & Phone Number

Detroit, Mi, Us

Rochester, Michigan, United States

• Assisted in the opening activities of new plasma centers, mentoring Quality Assurance Unit on the expectations and their role in overseeing the overall compliance of the facility.• Mentor all staff in achieving a more in depth understanding and application of cGMPs.• Maintain thorough familiarity with State, Federal and EU regulations, approved Standard Operating Procedures (SOP), OSHA, CLIA, and cGMP.• Ensure compliance with SOPs and that SOP revisions are implemented correctly, effectively, and pro-vided the necessary efficiencies through Quality System process assessments.• Work with center QAM and Center Management to develop Corrective Actions for inspection find-ings; ensure they are implemented and effective. Provide oversight and support to ensure responses are appropriate and complete.• Perform desk audits of available center databases to ensure continued compliance with performance and electronic documentation requirements• Assist in the preparation and hosting of inspections by various regulating agencies as well as facilitat-ing responses in a timely manner.

Madison Heights, Michigan, United States

• Oversee quality activities and manufacturing records to ensure they maintain compliance with SOPs and external regulatory requirements.• Provides direction and oversight of Quality staff ensuring all tasks are completed within required timeframes as well as provides coaching and mentoring to aid Quality department in achievement of career goals.• Certified as a quality trainer and responsible for training Quality department to uphold company's mission of providing the highest quality plasma.• Analyzes tracking and trending data and determine assess the need for corrective actions.

Perform quality assurance and control functions; ensure compliance with internal and external regulations, protocols, and policies.Stay current with SOPs and trainings in all production areas including medical screening, donor floor technician, phlebotomy, and lab processingReview equipment validations, calibrations, and maintenance records to ensure they are performed correctly and before deadlinesPerform audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems, assets in all audits (internal and external)

Madison Heights, Michigan, United States

• Screen all applicant donors to evaluate whether they are suitable to donate including vitals, hema-tocrit levels, total protein levels, etc.• Follow all Standard Operating Procedures to ensure donors health and product are of the highest quality and educate donors on how to have a successful donation.• Provide direction and outstanding customer service to ensure timely and efficient processing of all potential donors.

Mount Pleasant, Mi

Investigation; Execute experiments; replicate data for quality assurance; evaluate research; determine and evaluate findings; present research findings; analyze results; compare research findings with hypothesis; mentored by PhD chemist