Quality Control Manager
Resume:
Robert J. Van Zile
Pine Beach, New Jersey 08741
732-***-**** (Cell)
acuz9d@r.postjobfree.com
SUMMARY
Strong technical knowledge of analytical instrumentation, cGMP and FDA regulations; extensive experience with many types of solid dosage products; excellent communication and decision-making skills as demonstrated by twenty-three years of managerial experience; have hands-on type leadership skills and creates a teamwork atmosphere.
PROFESSIONAL EXPERIENCE
DPT Laboratories Inc.
745 Airport Road
Lakewood, NJ 08701
Manager, Quality Control Laboratory March 2015 to April 2016
Responsibilities: Have oversight of Analytical chemistry for finished products, raw materials, packaging components, spray characteristic testing and Water Testing departments. Drive quality for the facility by using Statistical Monitoring software (SigmaZone) and working closely with Manufacturing and Quality Assurance.
Accomplishments: Managed the Quality Control department and improved the efficiency, quality and cost effectiveness of the department. Created a positive environment in a high volume testing, highly stressful atmosphere. Drove change to improve and changed the culture of the department to think outside the box. Designed a departmental restructuring of fifty employees to improve quality and efficiency. Mentored Laboratory Supervisors and Group Leaders. Hazardous waste and DOT certified (49 CFR 172.704 and US EPA-RCRA (40 CFR 265.12). Performed investigational writing, CAPA setting and implementation using TrackWise computer system. Lead person on QC Laboratory design and relocation project.
Meda Pharmaceuticals Inc./VIVUS Inc.
745 Airport Road
Lakewood, NJ 08701
Manager, Quality Control Laboratory July 2007 to March 2015
Responsibilities: Have oversight of Analytical chemistry, method development and of Microbiologists in the Environmental Monitoring and Water Testing area.
Accomplishments: Managed the Quality Control department and improved the efficiency, quality and cost effectiveness of the department. Upgraded equipment, software and test methods to improve the efficiency of testing and minimize cost. I successfully managed the department budget. Am member of ISO14001 management team and safety committee. Hazardous waste and DOT certified (49 CFR 172.704 and US EPA-RCRA (40 CFR 265.12). Created company policy and customized computer software for statistically monitoring the quality of the manufacturing process. Created statistical criteria to follow that monitors the product results for trends and process capability (Six Sigma). Process Control Charts and Capability charts were used to drive quality for the product. Provided clinical stability testing and technical advice for new drugs for obesity and erectile dysfunction that later receive FDA approval.
Robert J. Van Zile
109 Avon Road
Pine Beach, New Jersey 08741
732-***-**** (Cell)
acuz9d@r.postjobfree.com
Supervisor, Quality Control Laboratory August 2006 to July 2007
Responsibilities: Supervise five chemists in the QC testing area; coordinated and prioritized projects (i.e. Stability, Release, In-Process, Instrument Validation and Calibrations); ensured laboratory instruments and equipment were validated; reviewed analytical data; conducted laboratory investigations, both Atypical and Out-of-Specifications; ensured chemists were qualified and trained to perform job responsibilities; wrote annual performance reviews for employees; completed investigation reports, scientific study protocols, test procedures, and
SOP’s; interviewed and assisted in the hiring of QC Chemists. Assist in supervising the
Microbiologists in the Environmental Monitoring and Water Testing area.
Accomplishments: Supervised and successfully completed four instrument validations. Assessed the QC laboratory and improved on cGMP practices and procedures. I helped provide tools to assess atypical results. I improved the training qualification process. Supervised the revision of three test methods. Participated in FDA and MHRA inspections. Continue to lead and develop personnel to achieve high quality standards.
Schering-Plough
1011 Morris Avenue
Union, New Jersey 07083
Supervisor, Analytical Testing, Quality Control July 1996 to June 30, 2006
Responsibilities: Supervised seven chemists in the QC testing area; coordinated and prioritized projects (i.e. Stability, Release, In-Process, Complaint, Method Transfer, and Validation); ensured instruments and test methods were validated; reviewed analytical data; conducted laboratory investigations, both Atypical and Out-of-Specifications; ensured chemists were qualified and trained to perform job responsibilities; wrote annual performance reviews for employees; completed investigation reports, scientific study protocols, test procedures, and SOP’s; interviewed and assisted in the hiring of QC Chemists.
Accomplishments: Responsible for the implementation of new test methods in the lab such as Assay and Estimation of Degradation Products; trained and developed employees; successfully completed new product launches (Claritin), which included method transfers; implemented proper "corrective actions and preventative actions" (CAPAs), which ensured the laboratory maintained compliance with cGMP's; evaluated and recommended new instrumentation; represented the QC Laboratory in the Pre-Material Review Board meetings; completed a Kepner-Tregoe training course (Problem-Solving Facilitator).
Senior Chemist, Quality Control December 1995 to July 1996
Responsibilities: Reviewed laboratory data from testing area chemists; performed analytical testing for Release, Stability, Complaint, Method Transfer, and Validation samples; assisted the Supervisor and acted for the Supervisor in his absence.
Accomplishments: Trained analysts to perform product testing and to use instruments properly; became the tablet testing area specialist on Zymark robotic dissolution systems.
Robert J. Van Zile
109 Avon Road
Pine Beach, New Jersey 08741
732-***-**** (Cell)
acuz9d@r.postjobfree.com
Analytical Chemist, Quality Control August 1993 to December 1995
Responsibilities: Performed release and stability analytical testing and instrument calibrations.
Accomplishments: Performed testing in an accurate and efficient manner.
Enseco East
2200 Cottontail Lane
Somerset, New Jersey 08873
Supervisor, Organic Preparatory Laboratory August 1991 to August 1993
Responsibilities: Supervised and managed an organic preparatory department with sixteen subordinates at an environmental testing laboratory; coordinated and prioritized various projects to meet customer needs; wrote test procedures; completed annual performance reviews; interviewed lab candidates and hired staff.
Accomplishments: Increased productivity by developing alternate test methods.
Lead Chemist, Organic Preparatory Laboratory June 1991 to August 1991
Responsibilities: Assisted the supervisor in prioritizing assignments; reviewed data; performed Pesticide/PCB and Acid/Base Neutral (ABN) sample analysis.
Organic Preparatory Chemist August 1990 to June 1991
Responsibilities: Performed sample preparations on Pesticide/PCB, ABN and Herbicide.
COMPUTER SKILLS
Excel, Word, Power Point, SigmaZone, ChemStation, Empower, TrackWise
VOLUNTEER
Member of the Pine Beach Land Use Board
Member of the Pine Beach Environmental Commission
EDUCATION
West Chester University
West Chester, Pennsylvania
Bachelor of Science in Biology/Ecology, 1990 Graduate
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