Quality Assurance
Resume:
RANDY S. JAMES
Fuquay-Varina, North Carolina 27526
PRODUCTION SUPERVISOR
QUALITY SUPERVISOR / QUALITY AUDITOR / QUALITY TECH.
PROCESS TECHNICIAM
Skilled professional with in-depth experience in quality assurance, Production
Management, including documentation, and compliance. Directed inspection
processes for incoming materials, in-process inspection and testing /
inspection of finished products. Fully versed in cGMP’s, FDA and other
agency requirements related to manufacturing operations. Operate and
maintaining equipment.
• Clinical Trial • cGMP, GLP, FDA. GCP • Compliance Audits
• Dimensional Analysis • Blueprints and Schematics • Statistical Process
Control (SPC)
• CAPA • Quality Assurance * Lean * CAD, EDS, ISO
Experience
BIOMERIEUX: DURHAM, NC JULY 2011 TO PRESENT
Process Technician
Working with GMP, Operate equipment and monitor
•
process to insure a quality product is being produce.
Perform change over in a timely manner to maximize
production, perform quality checks in a timely manner to
insure accuracy and to eliminate any delays in processing
product. Using acquire data fill out batch record to insure
neatness and accuracy to eliminate any delay in processing
product.
• Perform routine cleaning in area to insure there is no
contamination to product, fill out all cleaning logs in a
timely manner.
• Keep accurate data on any discrepancies found during
production run, and report all data to parties involved.
• Report all nonconforming issues to all parties involved; fill
out necessary documents in a timely manner.
• Pull samples, fill out all documents need to process samples
and enter samples information in log book.
• Make sure all batch record documents are correct before
being provided to quality personnel.
• Provide information during production to other shifts that
is necessary to eliminate production stoppage.
• Make sure all procedure pertaining to production process
is being followed using SOP and FDA requirements.
RING INDUSTRIAL Garner, NC June 2004 to JUNE 2011
Production Supervisor
• Supervise and direct the operational activities of a production team.
• Responsible for creating positive work environment, ensure
compliance with all internal and external guidelines for product quality,
associate training, and OSHA regulations.
• Implement standards, procedures and policies to support the
continuous improvement of product quality and production
efficiency and employee development in order to meet the
manufacturing goals and objectives.
• Serve as the first-line technical contact for the team in the event of
problems on the line.
• Investigate and solve technical process, equipment, or
material issues and initiate corrective action.
• Support development of plant associates through training initiatives
and cross train
Associates to achieve a flexible workforce.
• Promote teamwork and pride in the job, the team and the company.
• Complete performance evaluation and perform continuous
performance feedback.
• Select hire, train and appraise plant associates to attain the highest
quality standards of service and achieve optimal productivity levels.
• Operate shift according to budget. Maintain a highly motivated
workforce by providing timely communications, displaying an attitude
of consistency and fairness, and providing recognition for good
performance or ideas.
• Resolve any customer issues; maintain a high level of customer
satisfaction.
• Supervise truck drivers, and monitor driving logs for completeness.
EXPERIENCE
Westar Medical Inc. May 1999 To Jun 2004
Quality Supervisor
• Analyze and solve quality problems, select sampling plan applications,
prepare procedures, train lab technicians, perform audits, analyze
quality costs and other quality data, and apply fundamental statistical
methods for process control.
• Train and educate lab technicians/production personnel on procedures
and systems to maximize efficiency and ensure compliance to regulatory
and customer requirements.
• Provide technical quality direction to production personnel by
tracking production technical data and relating it to customer issues.
• Provide Quality guidance and recommendations to the production
department for raw material /finished product quality compliance,
including operator training on product and process specifications,
sampling, and inspection and test methods.
• Responsible for the inventory for equipment and supplies.
• Conduct capability studies and establishing control limits.
• Responsible for tracking and trending data and reporting results
through the use of various charts.
• Participate in customer audits and third party audits.
• Perform maintenance of various types of gages used for product
release.
• Assist in the development and implementation of training programs
to meet quality and regulatory functions and requirements.
• Trainer for manufacturing personnel/lab technicians on blueprint
reading, inspection and test methods, and the use of sophisticated
measurement/ testing equipment.
• Serves as authorized signatory for Certificate of Compliance.
EXPERIENCE
Clinical Trial Services, Durham, NC Nov. 1993 – June 1999
Quality Auditor
Implement and maintain the CTS quality systems, batch document review,
and product release. Assure that no product is release until its quality has
been deemed satisfactory having been manufacturing, processed packed and
held in accordance with CTS Standard Operating Procedures, current Good
Manufacturing Practices and customer specifications.
• Review and approve batch record documentation prior to customer
approval and use on the production floor.
• Review and release batch record documentation supporting documents
(logbooks, temperature charts)
• Review batch record supporting documentation(ire. Logbooks/humidity
charts)
• Coordinate the performance of investigations and corrections for
incomplete/unexplained issues found during the batch record review
process.(CAPA). Assist with the trending of batch record issues not
requiring an investigation or Quality Incident Report.
• Assist with the completion of internal facility audits.
• Ensure that CTS Standard Operating Procedures, current Good
Manufacturing Practices and customer requirements are adhered to in all
of work CTS.
• Generate non-conformance to address internal audit findings, identify
non-conformance containment.
• Participate in customer audits and third party audits.
• Serves as authorized signatory for Certificate Of Compliance.
Analyze and solve quality problems, select sampling plan applications, prepare
procedures, train lab technicians, perform audits, analyze quality costs and other
quality data, and apply fundamental statistical methods for process control.
• Train and educate lab technicians/production personnel on procedures
and systems.
Provide Quality guidance and recommendations to the production
department for raw material /finished product quality compliance, including
operator training on product and process specifications, sampling, and
inspection and test methods.
EXPERIENCE
T.R.W. STATION, Greenville, NC Feb 1985 to Nov 1993
Machine Technician/ Quality Coordinator
• Performed all duties related to the set-up, operation and maintenance of
steering and Suspension related equipment.
• Responsible for the operating and programming CNC machines,
operating lathes, mills, grinders, and presses.
• Responsible for machine setups, machine changeovers, troubleshooting
and repairing machines in a team concept environment.
• Responsible for other production related duties such as Production
Planner, Scrap Coordinator, Team Leader, and Quality Coordinator.
• Experienced in Blueprint reading, utilizing quality concepts such as
SPC, J.I.T. and TQM
• Proficient in the use of various quality gages such as calipers,
micrometers, comparators, height gages, and motion gages.
UNITED STATES ARMY, Honorable Discharge
Material, Accounting, Stock Control Specialist 1976 to Jan 1985
• Responsible for supervising Technicians, processing incoming
products, preparing product for shipment to customers.
• Responsible for maintaining stock levels, preparing inventory reports.
• Responsible for addressing customer complaints, processing customer
orders
• Responsible for conducting job performance reviews on subordinates
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