Quality Assurance Manager
Resume:
Brian Garrett
Baldwinsville, NY 13027
***********@*****.***
SUMMARY
Dependable supervisor with experience in a fast-paced manufacturing environment. Track record of being a quick learner with attention to detail and producing quality products in a timely manner. Combines technical skills with knowledge and experience to operate in an efficient, profitable manner.
Training and experience in:
Manufacturing Operations Good Manufacturing Practices
Production and Quality Management ISO9001
Continuous Quality Improvement GroupWise, FileMaker Pro, Word, Excel
EMPLOYMENT
RAM Fabricating, Syracuse, NY
08/2014-Present
Quality Assurance Engineer
● Define and implement process controls using statistical methods
● Train employees in the use of Quality Assurance Systems
● Analyze and evaluate process data, initiate corrective action to achieve
objectives
● Design and implement supplier certification programs
● Involved with company ISO compliance
● Initiate and resolve CARs
● Experience with PPAPs
● Safety Training
● Utilizing ways to help the company make money and save on spending
● Saved the company over $1,000.00.
Hanford Pharmaceuticals, Syracuse, NY 05/1993-07/2014
Production Team Leader (2009 - 2014)
Monitor the activities of 3 sterile fill technicians, 2 vial wash technicians and 2 vial packaging technicians, ensuring on time production startups and efficient fills on 3rd shift
Writing and performing variance investigations and corrective actions
Set up and operating equipment in a sterile and non-sterile environment
Responsible for work performance evaluations
Perform training of employees on shift
Perform continuous improvement techniques to reduce waste and improve yields
Ensure SOPs and safety procedures are implemented and updated
Perform mechanical adjustments on machinery when needed
Monitor HVAC continuous monitoring alarms
Environmental monitoring performed
Quality Assurance Team Leader/Supervisor (6 years)
Monitor the activities of 8 quality assurance auditors, as well as 2 quality assurance materials administrators over 3 shifts of production
Utilized modern inspection techniques including the appropriate use of go/no go gauges, calipers and micrometers
Performed training of personnel in quality department
Responsible of ensuring that daily activities, including the release of incoming and finished products, meet GMP standards and specifications as well as conforming to FDA regulations
Ensured standard operating procedures were followed throughout the company
Work with various departments, customers and vendor suppliers
Investigated and responded to customer complaints
Created "Paperwork Exercises" for GMP Training Program called "Paperwork Corrections" to give employees a better understanding of the typical paperwork mistakes made and the proper ways of filling out paperwork
Experience with printed/labeling materials
Trained on two vendor audits with Compliance Manager
Perform all aspects of variance investigations including writing/typing, reviewing, and approval
Performed approval of production orders/formula cards, as well as batch record reviews to ensure quality, accuracy and safety
Performed SOP revisions
Chart and logbook reviews
Experience in corrective and preventative action (CAPA) for equipment and process issues
Assisted Process Control Dept. with calibration of instruments, process and equipment validations
Quality Assurance Senior Auditor (2 years)
Quality Assurance Auditor (4 years)
Sterile Fill Room Technician (3.5 years)
Vial Wash Technician (1 year)
EDUCATION
Onondaga Community College, Syracuse, NY 2002
Achieved 4 credits in Production Management
Liverpool High School, Liverpool, NY 1986-1990
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