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Quality Assurance Manufacturing

Location:
Syracuse, NY
Salary:
45-55K
Posted:
December 16, 2013

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Resume:

Brian Garrett

*** ***** **** ****** # ***

North Syracuse, NY 13212

315-***-****

**********@***.***

PROFILE

Twenty years of manufacturing/pharmaceutical experience with expertise in production, quality assurance, and multi-tasking.

STRENGTHS

Skills and experience gained from employment, training classes, and education include:

*Supervisory Skills *Standard Operating Procedures

*Problem Solving Skills *Production/Quality Management

*Continuous Quality Improvement *Computer Skills

*Good Manufacturing Practices *Instrumentation Skills

EMPLOYMENT

GC Hanford Manufacturing, Syracuse, NY 1993-Present

3rd Shift Production Team Leader (3.5 years)

*Monitoring the activities of 3 sterile fill techs, 2 vial wash techs, and 2 vial packaging techs ensuring on time production start ups and efficient fills.

*Ensure daily goals and responsibilities are met.

*Writing and performing variance investigations and corrective actions when required.

*Performing setups, operating equipment in a sterile and non-sterile environment.

*Performing work performance evaluations.

*Ensure SOPs and safety procedures are implemented and updated.

*Perform mechanical adjustments on machinery when needed.

*Monitor HVAC continuous monitoring alarms.

*Environmental monitoring performed.

*Forklift certified.

*Computer skills using Microsoft applications including Word, Excel, Internet Explorer, GroupWise, and FileMaker Pro.

*Effective communication, time management, teamwork and leadership skills.

*Excellent written and verbal communication skills.

*Strong background in document control.

*Practice and follow lean manufacturing concepts.

Quality Assurance Team Leader/Supervisor (6 years)

*Monitored the activities of eight quality assurance auditors, as well as two quality assurance materials administrators over three shifts of production.

*Utilized modern inspection techniques including the appropriate use of go/no go gauges, calipers, and micrometers.

*Responsibility of ensuring that daily activities, including the release of incoming and finished products, meet GMP standards and specifications as well as to conform to FDA regulations.

*Enforce standard operating procedures were followed throughout the company.

*Implement the total range of quality assurance including motivation, human factors, quality costs, audits, documentation, inspection, reliability, and maintainability.

*Apply good oral and written communication skills in working with various departments, customers, and vendor suppliers.

*Computer skills using Microsoft applications including Microsoft Office Word, Internet Explorer, GroupWise, and FileMaker Pro.

*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 they should be.

*Trained on two vendor audits with Compliance Manager.

*Attended daily morning meetings, weekly Environmental Review Board meetings, Quality Improvement Team meetings, Non-Conformance Review Board and ship status meetings.

*Performed 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 in responses to corrective actions, accuracy in SOPs, or to implement a new system to expedite work flow.

*Chart and logbook reviews.

*Experience in corrective and preventative action (CAPA) for equipment and process issues.

*Experience with labeling materials including labels, inserts/outserts, and cartons.

*Assisted Process Control dept. with calibration of instruments, process and equipment validations.

*Annual product reviews and written reports.

*QA Investigation reports for ERB.

*QC alert responses.

*Effective communication, time management, teamwork and leadership skills.

*Excellent written and verbal communication skills.

*Experience in all phases of batch production records, labeling records, manufacturing records, and finished product testing.

*Strong background in document control.

*Practice and follow lean manufacturing concepts.

Quality Assurance Senior Auditor (2 years)

Quality Assurance Auditor (4 years)

Sterile Fill Room Technician (3.5 years)

Vial Wash Technician (1 year)

Sam's Club (PT), Clay, NY 2008-2009

*Photo Dept./Electronics Dept.

Time Warner Security (PT), Syracuse, NY 2007

*Security Monitoring Operator

TAD Temporary Services, Syracuse, NY 1992-1993

*Warehouse/Factory Worker

Qualex Inc., Liverpool, NY 1992

*File Clerk

Ernestwell, Ltd., Liverpool, NY 1991-1992

*Paper Factory Worker

Loss Prevention of Ames Dept. Store, Mattydale, NY 1991

*Store Detective

Steinbach Dept. Store, Cicero, NY 1990-1991

*Shipping and Receiving

TJ's Big Boy Restaurant, North Syracuse, NY 1987-1990

*Salad Bar/Buffet Attendant

EDUCATION

Onondaga Community College, Syracuse, NY 2002

*Achieved 4 credits in Production Management.

Liverpool High School, Liverpool, NY 1986-1990

* Achieved diploma; extra courses taken: Business Computers, Journalism, Speech, Drama.

Additional Training:

*Completed numerous company-sponsored training programs including Supervisory Skills.



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