Katherine Proctor
KBI BioPharma
High Point,NC
15
years of professional experience
A customer-focused, meticulous Quality Leader with over 17 years of experience managing teams, team building, cGMP, compliance, and pharmaceuticals. Collaborates effectively with all levels of personnel using good business communication skills.
Work History
Quality Assurance Regulatory & Compliance Specialist
5 Years- Responsible for quality oversight of all cGMP deliverables related to manufacturing | Ensures readiness for room conditions, equipment, and materials | Supervises document status, manufacturing executed in-process data, and document reviews | Responsible for the establishment of Quality policies, systems, and procedures to maintain best practices and maintain alignment with regulatory guidance | Manages Client Quality Agreement, deviations, and automated Quality Systems | Ensure risk assessments are completed and recommend changes to Standard Operating Procedures (SOPs) | Performs Quality assessments on equipment and facility procedures for specific manufacturing process units.
Manufacturing QA Supervisor
1 Year 11 Months- Managed the development of 10-14 Quality Technicians | Performed dispositions of non-conforming products | Initiated root cause analysis exercises | Assisted Production in resolving quality concerns | Generated and approved planned deviations | Managed the creation and revision of SOPs | Developed and approved work instructions | Successfully worked with global technical services to troubleshoot problems in production.
QA Technician III
5 Years 2 Months- Conducted routine quality checks and recorded data | Performed pre-batch inspections, checked equipment to verify readiness, and in-process quality control checks | Assisted Quality Engineers with production-related investigations | Implemented corrective actions | Supported management with providing SOP, cGMP training, and development of co-workers.
Quality Assurance Inspector
2 Years 5 Months- Inspected products for quality compliance, identifying defects and ensuring adherence to industry standards.
- Conducted thorough audits of manufacturing processes, improving operational efficiency and product reliability.
- Collaborated with production teams to implement corrective actions based on inspection findings, enhancing overall quality control.
- Trained new staff on quality assurance procedures, fostering a culture of safety and accountability within the team.
Education
Associates of Applied Science - Biotechnology
GPA: 3.5
High School Diploma
Skills
Assisted teams with compliance activities in CGMP programs.
Supported quality system initiatives through adherence to standard operating procedures.
Participated in quality assurance training to enhance pharmaceutical knowledge.
Contributed to written and oral communication efforts for effective information sharing.
Aided in the development of work instructions for streamlined processes.
Helped maintain organized document management systems.
Facilitated preparations for regulatory inspections.
Timeline
Quality Assurance Regulatory & Compliance Specialist
KBI BioPharma
08.2021 - CurrentRead More
Manufacturing QA Supervisor
Herbalife Nutrition
09.2019 - 08.2021Read More
QA Technician III
Herbalife Nutrition
07.2014 - 09.2019Read More
Quality Assurance Inspector
Vitacost
02.2012 - 07.2014Read More
Trinity High School
High School Diploma
Read More
Forsyth Technical Community College
Associates of Applied Science from Biotechnology
Read More