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Click here or scroll down to respond to this candidateCandidate's Name
Microbiology centered Quality Assurance ProfessionalPHONE NUMBER AVAILABLE (H)PHONE NUMBER AVAILABLE ( C ) QA/QC of reports and data. Root Cause Analysis/ investigation ofQuality Events. Over 30 years experience as a Microbiologist Extensive Laboratory Management experience Excellent interpersonal/verbal and written communication skills. Successful management/teamwork/leadership/training/presenting experience. Strong analytic and problem solving skills. Substantial expertise scientific process and procedures. Highly skilled in microbiology techniques, terminology and equipment and supplies In depth knowledge of laboratory tests used in microbiology work Hands on experience in diagnostic problems involved in determining the cause and control of contamination Proficient in methods and practices of microbiological analysis Demonstrated ability to prepare technical reports and research papers. Successful in the handling of FDA, customer, and other regulatory agency auditsVital Health America- Fairfield NJQuality Control ManagerJan 2024 - April 2024Brought an unused microbiology lab back into compliance and trained employees in the execution of elimination microbiology. Oversaw the duties of 5 chemists and one administrative scientist in a very high release manufacturing situation. Coordinated lab release of raw materials with manufacturing, sales, and sponsors to suit the best production situations.Minaris Regenerative Medicine- Allendale NJQuality Assurance Trainer ContractOct-Dec 2023Prepared technical training documents and exercises for the Quality Assurance Department pertaining to the launch of commercial blood cell gene therapy manufacturing for sickle cell anemia.Nelson Laboratories/Gibraltar Laboratories- Quality Assurance Auditor Fairfield NJ February 2016-June 2023The original company of Gibraltar Laboratoratories, conducted Quality Control of Microbiological reports, tailoring the reports to customer specifications, and reviewing the data to ensure that USP and Internal specifications had been covered. The company was purchased by Nelson Laboratories, then the role evolved into a true Quality Assurance one, conducting root cause analysis and Investigations of Quality Events with a specification in the microbiology testing being perforNovel Ingredient Services - East Hanover NJ February-June 2015Microbiologist Contract PositionSet up a new Microbiology laboratory under budget and ahead of schedule.Began the raw materials testing inhouse. Oversaw the retesting of a large volume of inventory and participated in the disposition of such. Established the Standard Operating procedures and began the basic laboratory validation of equipment and methods. Brought the new Quality department through its first audits.Solgar Vitamin and Herb- Leonia NJ September 2000-August 2014MicrobiologistPerformed microbial limits,water,air,environmental, and challenge testing leading our division in lab turnaround time.Trained and supervised temporary personnel in a very wide scope of testing and scientific thinking. Maintained an extensive method and equipment validation program that was remarked upon by the FDA as a model for completeness and accuracy. Validated a USP water system, above and beyond the requirements of nutraceuticals. Responsible for lab audits from the FDA, TGA, and various private agencies. Conducted informative lab tours for to Solgar vendors and sales staff on microbiology testing and probiotic supplements, making microbiology accessible for professionals with no biology experience. Provided further support to Sales, marketing and Research and Development in the form of writing and original experimentation that they could understand. Certified in HACCP methods and conducted extensive cleaning validation programs as the point of contact between Quality and Manufacturing.Microbiology SGS US Testing -Fairfield NJ May 1999-September-2000SupervisorManaged 6 technicians as a working supervisor in a wide range of of test procedures for pharmaceutical, food, cosmetics, and speciality industries. Testing included microbial limits LAL, Sterility, Preservative effectiveness challenge, biodegradation, and many AOAC procedures, done for the first time with no training. Designed an easy to retrieve system for the culture collection.Reheis Inc. -Berkeley Heights NJ February 1994-May 1999Senior MicrobiologistHandled laboratory management as the sole microbiologist. Performed daily microbial limits testing on bulk pharmaceutical raw materials and finished antacids. Initiated water testing and preservative effectiveness challenge testing. Wrote Standard operating procedures, gave presentations to both company executives and union personnel. Coordinated a cleaning validation program including microbial and chemical testing from the ground up.Certified the validation of outside packaging vendors. Responsible for micro lab audits from the FDA and private customers including most NJ pharmaceutical companies. Closely worked with management on a new system of document retrieval in order that all data remain accessible.Biocraft -Waldwick NJ August 1993-February 1994Microbiology ManagerSupervised and coordinated the activities of five microbiologists and two union personnel. Assigned work, influenced cooperation and high productivity. Investigated and responded to customer complaints and plant contaminations in five locations.December 1988-August 1993OrganonMicrobiologist Dec 1988- Aug 1993Performed QC micro analysis of raw materials and finished parential products. Testing including microbial limits, preservative challenge,LAL (product, water, oven effectiveness),Sterility,and water. Sterile gowning required. Handled FDA audits.Penco of Lyndhurst-Lyndhurst NJ March 1986-December 1988MicrobiologistPerformed Bulk microbial limits and water testing, worked directly with the production director and management as the sole microbiologist.Responsible for FDA audits.Avon Products Suffern NY August 1983-January 1985MicrobiologistPerformed preservative challenge testing as part of the corporate microbiology group.EducationBachelor of Arts, Douglass College of Rutgers University, May 1983, major Biology concentration microbiologyCertificationHACCP CertificationPharmaceutical Quality Assurance Certification, NJ Pharmaceutical AssociationNational Registry of Microbiologists Consumer Products American Society of MicrobiologistInterests: Skiing, Hiking, Isshin ryu Karate (Black belt 3/15/2015), photography, medieval recreation |
