Valerie Archuleta

A Material Review Board (MRB Chair)

I am responsible for reviewing and resolving defects and nonconforming conditions in assemblies, documenting and determining if abnormalities are related to engineering issues, and ensuring corrections will not negatively affect the functionality of systems I have to make the right decisions about non-conforming materials quickly and reduce scrap and rework where possible as the MRB chaired from the quality department, I run weekly meeting with the other MRB members that include representatives from purchasing, production, project management, with the task is to meet for just a short while to tackle the status of non-conforming items. MRB process is for a questionable batch that is “waiting for MRB decision” to be placed in a designated area and quarantined, this means not used for production until a positive decision has been made by the MRB chair -

QA Admin Duties

Taking care of QA/QC reports for the company such as KPI (Key Performance Indicators) reports for each dept. which include certificates, calibration, test results, inspection requests, non-compliance reports and site instruction/observations, and other QA/QC documents. Responsible for the closure of Non-conformance, Nonconformance Report, NCR, and Site Instruction.

Performs complex mechanical, electrical and visual inspection of incoming vendor supplied parts and

assemblies. Advanced surface plate setup for mechanical inspection of parts, mechanical inspection of

parts, including inspection of features within .001", electrical component and wiring diagram inspection

of electrical control panels manages inspection tool calibration recall program, travels independently to

supplier manufacturing sites to perform source inspection, Performs Final Product Audit in manufacturing

area. Provides Training to new inspectors by illustrating and demonstrating inspection techniques.

Quality Assurance Auditor for all intermediate and finished product batch records in the pharmaceutical

operations at the GPSG Vacaville facility. Responsible for in process audits of production lines to

assure conformance to regulatory commitments, internal procedures and documentation requirements.

Responsible for review of the manufacturing batch records for finished and intermediate products to

assure compliance with Master Formula, Quality Standards, SOP's and cGMP's and product quality,

Performed daily inspections of facility and lines for overall conformance. Approved lines for commercial

manufacturing, resolved level 1 non-conformance. Performed in-process sampling and testing as well

as collect data for compliance trends. I assisted in developing compliance training programs for the

production teams. Facilitated Training to all scheduled shifts on site and interacted frequently with

production management, engineering, and maintenance departments to resolve issues relating to quality

and compliance.

Audit manufacturing batch records of finished product for compliance with the master formula, Quality

Standards, SOP's and cGMP's to assure product Quality and regulatory compliance. Release product to

distribution in a timely manner, Interact with productions supervisors and operators, process engineering,

Planners, QA Capa any other areas to assure that any product quality and compliance issues have been

addressed. I am highly experienced in MFG-PRO, ExRx and word and excel programs designed for QA

Product Release. I audited and revised production documents reducing documentation error rate by 80%

and improved on-time shipments 110%.

Provided Direction for 6-10 Operators, Filled in for supervisors and managers in their absence.

Operator Manufacturing, Performing all Manufacturing operations, Specializing in mixing, weighting, sampling, running the form

fill and seal casting machines, Also QAD Certified performing line sign offs.

• Organized daily workflow, delegated tasks to team members, and monitored progress.
• Trained new employees on company policies, procedures, and safety regulations.
• Provided guidance to team members while ensuring quality assurance standards were met.
• Scheduled regular maintenance activities to maintain equipment performance levels.
• Assessed employee performance through regular reviews and provided feedback as necessary.
• Reviewed work orders for accuracy prior to processing them for production purposes.
• Monitored the production process for adherence to quality control requirements.