Sandra Oates
Lexington,NC
Summary
Document Control Specialist with 10 years of GMP/GLP & FDA regulatory experience in both Medical Device and Food manufacturing industries. Familiar and comfortable with paper-based and electronic document control procedures in a GMP regulated environment. Proficient in Microsoft Word formatting and document management. Excellent eye for detail and highly organized. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Ability to handle multiple projects simultaneously with a high degree of accuracy. Willingness to take on added responsibilities to meet team goals.
Overview
15
15
years of professional experience
Work History
Sr Document Control Coordinator
Herbalife Nutrition Ltd.
08.2020 - Current
- Assist management with approval or rejection of finished goods work orders.
- Review of documentation – test results for raw materials, components and QA inspection documentation to assure material meets specifications.
Review and approval of Master Manufacturing Records (MMRs), Reprocessing Approvals, Planned Deviations, Document Change Requests, Change Control Requests, LIMS templates. - Ensure adherence with GMPs and SOPs.
- Determine disposition of finished goods and release or reject as appropriate.
- Assisting in determination of corrective action as required.
- Assist management in conducting formal procedural inquiries and investigations to determine cause of quality problems, recommend verbal and/or written corrective action to management as required.
- Review documentation and identify trends; provide detailed written observations to management as appropriate.
- Interact effectively with co-workers and management in order to resolve problems.
- Assist management with development of departmental goals and objectives.
- Performs other related duties as assigned by management.
Regulatory Affairs/Quality Assurance Specialist
Carolina Liquid Chemistries
05.2018 - 08.2020
- Compose, revise and maintain controlled documents including standard operating procedures (SOP), work instructions or policies within quality system.
- Recommended changes to current procedures and practices in response to regulatory changes.
- Ensured all employees were trained in regulatory guidelines such as GMP, GLP, and GDP
- Prepare CAPA, NCMRs and NCR and root cause analysis
- Played vital key role in both internal and external audits with FDA & ISO
- In conjunction with study director, provided technical review of data and prepared data and reports that were incorporated in FDA 510(k) premarket submissions and CLIA categorizations
- Reviewed batch records and labeling to ensure compliance with regulatory agencies and audit responses
- Developed or tracked quality metrics.
- Coordinated recall or market withdrawal activities as necessary.
- Developed and implemented procedures to meet product quality standards. Recommended improvements to processes.
- Implemented regulatory guidance procedures.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Maintained and archived regulatory paperwork.
- Assisted with Safety Risk Management (SRM) process. Executed analysis of risks and identified risk mitigation strategies.
- Developed and implemented procedures to meet product quality standards
QA Specialist/Document Control
Ameritox
04.2013 - 05.2017
- Prepare solutions for QA/QC, Chemistry, and LC/MS Confirmation Departments
- Participate in validation of solutions, methods and method improvements
- Assist with troubleshooting issues regarding QC solutions and related laboratory equipment
- Assisted Department Supervisors in maintaining training curriculums as needed.
- Responsible for distributing and retaining training materials and competency evaluations for all lab employees
- Managed laboratory records and logs and ensured that are retained in accordance with CLIA and CAP requirements
- Compose, revise and perform annual reviews, of all SOPs and Policies
- Maintained SOP Change Request database and handled each request accordingly.
- Support QA Manager in maintaining Laboratory licenses and aid employees in obtaining required state license/certification necessary for their positions
- Works closely with QAQC Director in developing quality assurance policies and procedures and assist in internal auditing process in preparation for external audits from accrediting agencies
- Performed training to all new employees during New Hire Orientation and provided continuing education for current employees in OSHA regulations, GLP, & GDP
Office Manager/ Call Center Supervisor
Jackson Hewitt
01.2008 - 04.2013
- Prepared Individual Tax Returns
- Managed all aspects of retail store front including cash handling, nightly deposits, and completed all required reports and documentation.
- Supervised and trained 20 employees in office procedures, tax preparation and audited all preparation of tax returns.
- During 2010 tax season implemented call center to answer incoming calls for all 62 offices within district. Hired, trained and supervised 15 call center employees
- Awarded 2009 Office of the Year for excellence in sales, revenue, productivity and customer retention.
Education
Associate of Science - Applied Science-Biotechnology
Alamance Community College
Burlington, NC12.2012
Skills
- Interpersonal Communication
- Written Communication
- Teambuilding
- Multitasking Abilities
- MS Office
- FDA Regulations/Compliance
- GMP and ISO Compliance
- Excellent Communication
- Training and Development
- Excellent Problem-Solving Skills
Quote
I have not failed. I’ve just found 10,000 ways that won’t work.
Thomas Edison
Timeline
Sr Document Control Coordinator
Herbalife Nutrition Ltd.
08.2020 - Current
Regulatory Affairs/Quality Assurance Specialist
Carolina Liquid Chemistries
05.2018 - 08.2020
QA Specialist/Document Control
Ameritox
04.2013 - 05.2017
Office Manager/ Call Center Supervisor
Jackson Hewitt
01.2008 - 04.2013
Associate of Science - Applied Science-Biotechnology
Alamance Community College
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