Experienced in production and Quality Assurance in the pharmaceutical medicine and medical device manufacturing as well as industrial steel and electronics. Qualified for Class A sterile and non-sterile manufacturing. Responsibilities have included: technical writing, process validation, supplier certification, document control, non-conformancepackage design, statistical analysis and process improvement as well as software implementation.. Held a secret clearance for ten years and am currently registered with the DEA to handle and transport controlled substances.
Quality Assurance Inspector February 2014 to CurrentDPT Laboratories － Lakewood, NJ
Monitor solid, liquid, and inhalant product quality through all manufacturing processes Ensure all manufacturing documentation requirements and SOPs are being followed Review the manufacturing paperwork for accuracy and compliance, during and upon completion of activities Report and investigate non-conformances associated with procedures, components, and finished products Collect representative samples and submit for testing and retention including all relevant paperwork Inspect and approve manufacturing/packaging rooms, lines and equipment prior to use Inspect and approve all necessary components and bulk medicines.
Ensure all work performed is documented accurately and completely in batch records, forms, logs and other documents Provide training to QA and Operations staff on proper documentation and inspection procedures Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines Transport controlled substances to and from secure locations before and after manufacturing activities per DEA guidelines.
Quality Assurance Manager March 2008 to March 2013TPS Associates, Incorporated － Manchester, NJ
Investigated non-conformance issues related to manufacturing, inventory control, and customer complaints Created manufacturing records and standard operating procedures for all manufacturing activities Evaluated Engineering Change Proposals and Maintenance Plans and communicated with system engineers to resolve any resulting technical conflicts Established suitable goals, timelines, training, development and succession planning of direct reports Provided support for QA Operations and System groups during regulatory agency and customer inspections Performed internal audits and enforcemed GMP compliance on the production floor Led the implementation of cGMP in internal operations and ensured compliance to Department of Defense requirements and procedures.
Provided quality input, oversight and assessments for all non-conformance events on and off site.
Managed quality oversight of third party manufacturing production and release.
Provided TPS management and government clients with accurate and realistic cost estimates for technological assets, manufacturing components, and support equipment Proficient in document and technical writing, editing, and analysis Provided TPS management and government clients with accurate and realistic cost estimates for technological assets, manufacturing components, and support equipment.
Manufacturing Manager March 2004 to March 2008TPS Associates, Incorporated － Manchester, NJ
Training and mentoring manufacturing technicians and support personnel in Good Manufacturing Practices and Good Clinical Practices Implementing Good Manufacturing Practices and standards centered around efficient work protocols, increasing production while lowering risk of errors and non-conformance issues resulting in between 6 and 13 million dollars annual revenue during my tenure Maintaining strict inventory of all manufacturing parts, tools, and supplies in accordance with Good Clinical Practices Ordering and or procuring parts, tools, and components in accordance with specified bill of materials Assembling and or constructing support equipment and devices according to specification drawing packages and Good Manufacturing Practices Collaborating with government and outside contracted entities relating to manufacturing Providing regular written progress reports to government clients and customers Controlling access to bonded storage housing government furnished equipment and ensuring electronic files pertaining to the Department of Defense are protected per the Federal Information Security Management Act.
Packaging Manager July 2002 to February 2004Hampton Forge LTD － Eatontown, NJ
Lead Designer on all products and packaging designs Supervised and coordinated of Creative Department working within a budget to procure supplies, computers, and creative computer program acquisitions for the Graphics Department Prepared graphic art files for packaging and marketing with emphasis on quality, accuracy and production efficiency.
Performed Quality Assurance on all product samples and final packaging for production approval Coordinated designs and specifications for sample creation as well as communicating order requirements with manufacturing entities in China.
Quality Assurance Inspector / Technical Writer April 1998 to March 2002VIVUS Mfg － Lakewood, NJ
Participated in procedural reviews with Production, Quality Assurance, and Document Control professionals Updated and created written Standard Operating Procedures Reviewed batch records for product release Conducted and reviewed investigations for deviations and non-conformances Participated in and performed Quality Audits Provided support on monitoring, review and release of finished product Represented QA in cross functional teams and projects Conducted compliance trainings for all personnel within my scopeof responsibility Oversaw compliance for filling rooms and packaging line operations Supported QA Operations and Compliance groups during regulatory agency and customer inspections Conducted audits of Manufacturing Facility to ensure compliance with CGMP, Corporate and site SOPs Provided QA support to Manufacturing for clinical and commercial batches.
NAVAIR Command ECPs for Engineers Course Certified EPC Specialist January 2009, 2010, 2011 Association Connecting Electronics Industries Certified IPC Specialist Serial Number 42242 : February 2013
BS Degree : Business Management and Marketing, June 2008American Intercontinental UniversityBusiness Management and Marketing
Certification in Graphic Design : March 2002Brick Computer Science Institute
NAVAIR Command ECPs for Engineers Course Certified EPC Specialist January 2009, 2010, 2011 Association Connecting Electronics Industries Certified IPC Specialist Serial Number 42242 : February 2013 BS Degree : Business Management and Marketing , June 2008 Certification in Graphic Design : March 2002
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