Kimberly Rehner
Roanoke Rapids,NC
Summary
Experienced with quality control processes and assurance procedures. Utilizes meticulous testing and inspection techniques to ensure product quality. Knowledge of industry standards and regulatory requirements, ensuring compliance and high-quality outcomes.
Overview
22
22
years of professional experience
Work History
Lead QC Asssociate II
FUJIFILM Diosynth Biotechnologies
04.2019 - 05.2023
- Enhanced product quality by implementing rigorous testing procedures and protocols.
- Trained new QC associates on company policies, procedures, and best practices to ensure a high standard of work across the team.
- Identified areas for improvement in manufacturing processes, leading to a reduction in defects and increased customer satisfaction.
- Evaluated new tools and technologies for potential implementation within the QC department, optimizing workflows for increased productivity.
- Reviewed technical documentation for clarity and accuracy, contributing to seamless communication between teams involved in product development processes.
- Developed strong relationships with suppliers, fostering open communication channels for addressing quality concerns promptly.
- Spearheaded root-cause investigations into non-conforming materials which led to swift identification of problem sources and targeted corrective actions.
- Collaborated with production team, ensuring alignment of goals and continuous improvement in product quality.
- Coordinated cross-functional efforts aimed at resolving identified product design flaws that resulted in significant improvements in overall performance.
- Conducted root cause analysis on reported issues, providing actionable insights for resolution and prevention of future occurrences.
- Streamlined QC processes for improved efficiency and accuracy in identifying defects.
- Ensured compliance with industry regulations by staying current on updates and incorporating necessary changes into daily operations.
- Participated in audits of internal processes, demonstrating commitment to maintaining high-quality standards throughout the organization.
- Championed a culture of continuous improvement by initiating and participating in quality-focused projects aimed at optimizing processes and outcomes.
- Maintained detailed records of inspection findings, facilitating timely corrective actions and process improvements.
- Inspected items and compared against standards to meet regulatory requirements.
- Recorded and organized test data for report generation and analysis.
- Collected and analyzed data to measure effectiveness of quality control processes.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
Senior Chemist III
Merck
04.2018 - 11.2018
- Testing of stability/FP samples for assay, degradates, pH and moisture equivalent.
- Analyzed and interpreted laboratory data.
- Ordered, calibrated, troubleshot and maintained laboratory equipment in good working order.
- Troubleshot analytical issues, identifying root causes and implementing corrective actions.
- Performed techniques such as HPLC, GC, TOC and UV/VIS on assays and related substances.
- Completed physical, qualitative and quantitative tests.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
- Carried out laboratory tests and experiments to analyze, identify and isolate chemical compounds.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
Senior CQ Specialist
Hospira/Pfizer
01.2016 - 10.2017
- Performed a variety of testing for the Analytical Services Department per USP, EP, Stability, Validation and TSR (special request testing).
- Proficient with HPLC, UPLC, GC and various instruments required for wet chemical testing for Raw Materials, In-process, Final Product, Special Request, Validation, Stability and new drug applications.
- Responsible for troubleshooting instruments as needed.
- Certified as a trainer for new employees.
- Certified for parallel data review for other analysts.
- Proficient with LIMS, ThermoLims for Stability, Empower 2, Empower 3, ChemStation, TotalChrom and Trackwise.
- Responsible for maintaining cGMP, cGLP and Safety.
- Active member of 5S Team.
- Followed all company policies and procedures to deliver quality work.
- Designed employee recognition program that improved morale and reduced turnover.
SUPERVISOR OF QUALITY OPERATIONS/PACKAGING
Qualitest Pharmaceuticals
01.2013 - 04.2015
- Supervise Quality Technicians within the value stream. Work in unison with Packaging Supervisor and Operators for quality compliance.
- Responsibility and authority to approve or reject all in-process materials, bulk drug products and or in-process packaged products.
- Authority to review and evaluate Quality Control results for raw materials, intermediates, and finished products for thoroughness and accuracy.
- Initiate, investigate and provide final disposition for any non-conformances or deviations by use of Trackwise and NCR logs (Non-conforming Report). Propose and implement Corrective Action and Preventative Action (CAPA).
- Review and revise batch records and SOPs as required.
- Provide compliance support, expertise and training for Packaging Operations.
- Responsible for yearly cGMP training.
- Follow 21 CFR Part 210 & 211 in regards to manufacturing, processing, packing, or holding of drugs and finished pharmaceuticals.
- Work with Lean Manufacturing processes within the Packaging Department.
- Work with Packaging Department to initiate 6S procedures.
- Responsible for overseeing all protocols, change controls, etc. that involve changes or updates to equipment and and/or training of packaging technicians.
- Collaborated with cross-functional teams to drive continuous improvement initiatives throughout the organization.
- Enhanced team performance by providing regular training, feedback, and guidance to Quality Assurance staff.
- Oversaw onboarding and training of new employees to promote qualified and well-coordinated quality assurance team.
QCCA SCIENTIST/PROJECT DIRECTOR
Catalent Pharma
04.2010 - 12.2012
- Perform technical review for correctness and completeness.
- Initiate notebooks for product release and stability testing.
- Initiate investigations, deviations, out of specification results in Trackwise for non-conforming materials.
- Follow through with investigations to determine outcome.
- Responsible for maintaining Progressive 5S/6S procedures with weekly and monthly lab audits.
- Began Blackbelt training.
- Acquiring customer projects and contracts as the Project Director. Work one on one with various customers, internal and external for optimal testing results.
- Attend weekly forecast meetings for my department.
- Troubleshoot instruments, as needed.
- Work with analysts to help with their understanding of instruments and Compendia methods.
- Responsible for yearly cGMP and GLP training.
- Follow current 21 CFR Part 210 & 211.
- Responsible for initiating and updating customer protocols and stability testing protocols.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Implemented quality control measures to ensure the accuracy and reliability of experimental results.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Monitored project and program quality to meet audit expectations.
- Improved client satisfaction rates by effectively addressing concerns and incorporating feedback into future processes.
- Maintained compliance with regulatory requirements through diligent monitoring of documentation procedures during all phases of the projects.
- Managed cross-functional teams to ensure seamless coordination throughout all stages of the projects.
- Navigated challenging situations with diplomacy, resolving conflicts among team members while maintaining focus on project goals.
- Delivered high-quality results by adhering to industry best practices and maintaining a detail-oriented approach throughout each project phase.
- Reported regularly to managers on project budget, progress, and technical problems.
- Verified quality of deliverables and conformance to specifications before submitting to clients.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
Associate Scientist
Catalent Pharma
04.2010 - 12.2012
- Perform Compendia testing (USP, JP, BP, EP and FCC) for internal and external customers.
- Perform raw material, commodity, validation, and stability testing for internal and external customers. (USP, JP, EP and FCC)
- Responsible for complete compendia testing, stability testing, etc. by way of wet chemistry and chromatography.
- Parallel review of other Scientist's notebooks for thoroughness and completeness.
- Ability to work within group setting and independently.
- Responsible for cGMP and GLP yearly training.
QO Specialist /Packaging
Pfizer
04.2007 - 05.2008
- Coordinate and perform various Quality Assurance activities.
- Monitor and review of drug appraisals, device manufacturing and packaging operations for compliance of procedures, quality systems and cGMP (current Good Manufacturing Practices).
- Review for approval of incoming material and finished product lots.
- Responsible for product release, shipping and sales.
- Responsible for inventory control.
- Investigate and facilitate resolutions of quality issues and process deviations.
- Prepare specifications, procedures and documentation to support Quality Systems.
- Review and approve facility and equipment validation documents.
- Support supplier qualification program and participates in Quality audits for new, established and contract vendors.
- Followed all company policies and procedures to deliver quality work.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Assisted in developing strategic plan that aligned with long-term company goals.
- Led quality assurance efforts, maintaining high standards for all products and services.
- Conducted regular reviews of operations and identified areas for improvement.
QA Project Specialist/ Group Leader
Hospira/Pfizer
03.2005 - 02.2007
- Supervise 7 analysts.
- Responsible for auditing Chemistry, Biology, Raw Material, Validation and Stability data for product release.
- Initiate Non-Conforming Reports, Deviation permits and Out of Specification Investigations.
- Work as liaison between Clayton Quality Assurance and other departments such as One 2 One, Clayton Manufacturing and Hospira Rocky Mount Chemistry and Biology departments.
- Became proficient in testing requirements for emulsions, as well as, small and large volume solutions.
- Became proficient with medical devices.
- Served as member of project teams such as Hospira Chemistry Council and Rocky Mount Large Volume Glass Transfer.
- Compliant with cGMP, plant-wide and corporate wide SOP's and Laboratory Safety Practices.
- Fluent with LIMS, Microsoft Outlook and Excel.
- Cross trained in Microbiology and other Biology Quality areas.
- Responsible for lab investigations by way of SMART CAPA.
- Responsible for assisting analysts with instrument troubleshooting.
- Worked with other internal customers to develop and continue stability program.
Supervisor CQA Laboratory
Abbott Labs/Hospira Inc
08.2001 - 03.2005
- Responsible for up to 15 analysts.
- Responsible for batch record auditing and release of product.
- Initiate and review Laboratory Investigation Reports and Nonconforming Materials reports for product release or destruction.
- Compliant with cGMP, GLP, plant-wide and corporate SOP's, and Laboratory Safety Practices.
- Performed monthly safety audits for third shift.
- Audit lab notebooks for compliance.
- Reviewed, revamped and corrected batch records and SOP's for updates and errors.
- Cross trained with all other labs within CQA for product release.
- Fluent with LIMS, MS Word and Excel.
- Worked with LIMS administrator to update and correct testing information in LIMS.
- Worked with internal plant customers to expedite special request testing involving change controls and TSRs.
- Involved with multiple weekly hold list meetings to determine product release.
- Involved with weekly schedule meetings to ensure proper lab headcount to achieve in-process and final product testing requirements.
- Fluent with stability and ANDA requirements.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Increased team productivity by implementing efficient workflows and setting clear expectations for staff members.
- Resolved conflicts among team members promptly, maintaining a harmonious working environment conducive to productivity.
- Enhanced communication within the team by holding regular meetings and encouraging open dialogue among all members.
- Demonstrated commitment to the organization''s core values, leading by example and fostering a culture of excellence.
- Collaborated with other departments to achieve organizational goals, fostering teamwork across various functions.
- Conducted performance evaluations for staff members, identifying areas of improvement and guiding professional development plans.
- Developed staff skills through targeted training programs, resulting in improved performance and career growth opportunities.
- Identified operational inefficiencies and implemented corrective measures to increase effectiveness.
- Conducted thorough employee evaluations to identify areas for growth and development, leading to more skilled workforce.
- Maintained high safety standards to ensure secure workplace for all employees and visitors.
- Optimized scheduling to ensure full coverage during peak hours without overstaffing, balancing customer service with cost efficiency.
- Managed diverse team, promoting inclusive work environment that leveraged individual strengths.
Education
B.S - Chemistry
North Carolina Wesleyan College
Rocky Mount, NC05.1993
A. S. - Engineering
Halifax Community College
Weldon, NC08.1990
Skills
- Trackwise
- LIMS
- Empower
- SAP
- Laboratory techniques
- Batch record review
- Good manufacturing practices
- Sample testing
- Chemical handling
- Safety compliance
- Verbal and written communication
Awards
American Institute of Chemist, 04/01/93
Personal Information
- Willing To Relocate: Easter North Carolina
- Authorized To Work: US for any employer
- Title: Senior CQ Specialist/Quality Assurance
Accomplishments
- Resolved product issue through consumer testing.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Supervised team of 15 staff members.
American Institute of Chemist Award
The American Institute of Chemistry Program honors seniors in Chemistry, Biochemistry and Chemical Engineering The award is given in recognition of ability, leadership and professional promise. Candidates are nominated by their faculty members.
Timeline
Lead QC Asssociate II
FUJIFILM Diosynth Biotechnologies
04.2019 - 05.2023
Senior Chemist III
Merck
04.2018 - 11.2018
Senior CQ Specialist
Hospira/Pfizer
01.2016 - 10.2017
SUPERVISOR OF QUALITY OPERATIONS/PACKAGING
Qualitest Pharmaceuticals
01.2013 - 04.2015
QCCA SCIENTIST/PROJECT DIRECTOR
Catalent Pharma
04.2010 - 12.2012
Associate Scientist
Catalent Pharma
04.2010 - 12.2012
QO Specialist /Packaging
Pfizer
04.2007 - 05.2008
QA Project Specialist/ Group Leader
Hospira/Pfizer
03.2005 - 02.2007
Supervisor CQA Laboratory
Abbott Labs/Hospira Inc
08.2001 - 03.2005
A. S. - Engineering
Halifax Community College
B.S - Chemistry
North Carolina Wesleyan College
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