Kimberly Pieper Email & Phone Number

Mattawan, Michigan, United States

Communicate all identified compliance and quality risks to the next level of management. Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled. Manage 10 direct reports to assure that Quality Assurance responsibilities of applicable regulations are fulfilled. Assure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities. Schedule resources to manage compliance systems and time completion of work. Participate in Regulatory Affairs and Compliance projects and programs. Assure that Corporate Quality and Compliance Policies are implemented and administered at the site. Assist in development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans. Assist in the development and recommendation of the departmental budget and authorization expenditures. Develop and oversee the implementation of departmental training programs including orientation. Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.

Oversee daily operational activities and QA resources. Review, recommend and revise QA SOPs, protocols, reports, and other quality and regulated records for compliance with regulations. Participate in client site visits and regulatory inspections. Assure QA audit files are retained. Participate in the development of recommendations for corrective and preventative actions to respond to client visits and regulatory inspection findings. Assist with administering programs for measuring compliance and quality risk. Communicate and identify compliance and quality risks to management and make recommendations on how to properly address them. Assist in development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans. Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews. Lead a team of 10 direct reports one of which is a team lead.

Mattawan, Michigan

Oversee daily operational activities and QA resources. Ensure adherence to departmental policies, practices and procedures. Review, recommend and revise QA SOPs, protocols, reports, and other quality and regulated records for compliance with regulations. Participate in client site visits and regulatory inspections. Participate in the preparation and review of study and QA files in preparation for client site visits and regulatory inspections. Participate in client site visits and regulatory inspections. Assure QA audit files are retained. Participate in the development of recommendations for corrective and preventative actions to respond to client visits and regulatory inspection findings. Assist with administering programs for measuring compliance and quality risk. Communicate and identify compliance and quality risks to management and make recommendations on how to properly address them. Perform data and report audits to assess the records follow regulations, SOPs, protocols, policies and procedures to support department workload. Oversee maintenance of training records and manuals. Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews. Lead a team of 10 direct reports.

Mattawan, Michigan

Provide guidance by making recommendations for compliance and identifying, as well as collaborating to resolve and prevent potential issues. Responsible for performing independent assessment of protocols, laboratory procedures, data, reports, and personnel training to determine the level of compliance. Attention to detail with the balance of big-picture auditing. Take the initiative to make things better and use experience to strengthen the overall compliance of the company. Proactive in resolving issues and responding positively to the costumer’s needs.

Mattawan, Michigan

Provide guidance by making recommendations for compliance and identifying as well as collaborating to resolve and prevent potential issues. Responsible for performing independent assessment of protocols, laboratory procedures, data, reports, and personnel training to determine the level of compliance. Attention to detail with the balance of big picture auditing. Take the initiative to make things better and use experience to strengthen the overall compliance of the company. Proactive in resolving issues and responding positively to the costumers needs.

QA Team Lead position for the formulations department. Mentored and trained new QA team members. Assisted in the development, implementation, and process improvement within the department. Participate and assist with hosting sponsor visits. Interact with other departments and study directors on potential causes for concern with studies. Maintain accurate and timely reporting. Perform audits of study protocols for compliance with GLPs and departmental SOPs. Conducted in-process audits according to protocols, GLPs and departmental SOPs. Executed data and report audits according to protocols, GLPs and departmental SOPs. Maintained accurate Quality Assurance reports of inspections, as well as the Quality Assurance Master Schedule. Attended all study meetings. Specialize in the auditing of Analytical method validation, formulations sample analysis, Bioanalytical method validation, Bioanalytical sample analysis, Immunotoxicology sample analysis and method validation, and In-vitro pharmacology.

Assisted in the development and training of peers within the department on an as needed basis. Collaborated with upper management to organize and distribute work within the group in the absence of direct supervisor. Test article projections to assure that enough test material was on-site to complete a study. Quality reviewed all test material phases of study to assure compliance with study specific procedures as well as the protocol, SOPs and GLPs. Accurately collected and reviewed data to ensure compliance according to the protocol, SOPs and GLPs. Working with bulk material as it arrives from the Sponsor to formulate dose material. Daily calibration of laboratory equipment was conducted to ensure accurate and reliable data collection. Followed detailed, study specific instructions to prepare, sample, and dispense solutions, suspensions, dietary mixtures, sterile preparations, and capsules for dose administration.

Master Of Science - Ms, Leadership And Organizational Dynamics

Bachelor Of Science, Chemistry

Bachelor Of Science (Bs), Chemistry

Transferred to the University of Minnesota

Master Of Science - Ms, Chemisty