I have held lead or management positions in DoD Manufacturing QA as well as the Pharmaceutical solid, liquid, suppository, inhalant, Defense, and Medical Device Quality Assurance fields. Experienced with In-coming, components, bulk powder, In-process and Finished Product inspection and release. Sterile and Non-sterile manufacturing, process validation, supplier certification, document control, non-conformanceCAPA investigations, statistical analysis and process improvement as well as software implementation..
Quality Assurance Inspector02/2014 to CurrentDPT LaboratoriesLakewood, NJ
Monitor solid, liquid, and inhalant product quality through the performance of required visual testing Perform routine line clearances/in-process inspections on the packaging lines and compounding suites Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed Review the required paperwork for accuracy and compliance, both on line and upon completion of the activity Report non-conformances associated with components, in-process materials, finished products Collect representative samples for testing and retention, and ensure all relevant paperwork is complete Submit samples/resamples to laboratory in a timely fashion to meet production needs Inspect and approve manufacturing/packaging rooms, lines and equipment prior to use Inspect and approve packaging components.
Sample in-process items and finished products.
Perform required inspections and testing of in-process items and finished products Apply disposition labels to components, in-process materials and finished products Stage label and inserts on production lines, issuing reports and verifying customer and DPT part numbers and comparing information to the staging sheet Process and distribute finished and in-process samples, including raw liquids and bulk powders to other teams (i.e.
Quality Control Laboratory) for evaluation and testing Review records to confirm accuracy, completeness and GMP compliance 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 Gown qualified for Class 100 clean room operations Registered with the DEA to move and handle Class II narcotics.
Quality Assurance Manager03/2004 to 03/2013TPS Associates, IncorporatedManchester, NJ
Investigated non-conformance issues related to inventory control, including but not limited to component shortages, clerical errors and, incorrect components Proficient in document and technical writing, editing, and analysis Evaluated Engineering Change Proposals and Maintenance Plans and communicating with system engineers to resolve any resulting technical conflicts Responsible for upgrades to SOPs, and change controls.
Supported validation protocols and special projects 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 Assisted in performing internal audits and enforcement of GMP compliance on the production floor Led the implementation and maintenance of systems for assuring cGMP operations with external operations and ensure compliance to Department of Defense requirements and procedures.
Provided quality input, oversight and assessments for all non-conformance events 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.
Packaging Manager07/2002 to 02/2004Hampton Forge LTDEatontown, 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 Preparing graphic art files for packaging and marketing with emphasis on quality, accuracy and production efficiency.
Performing Quality Assurance on all product samples and final packaging for production approval Coordinating designs and specifications for sample creation as well as communicating order requirements with manufacturing entities in China.
Quality Assurance Inspector04/1998 to 03/2002VIVUS MfgLakewood, NJ
Quality Assurance in an ISO 9001 certified Life Sciences pharmaceutical plant 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 scope of responsibility Oversaw compliance for filling rooms and packaging line operations Supported QA Operations and Compliance groups during regulatory agency and customer inspections Participated in Operations Procedural reviews with Production, Quality Assurance, and Document Control professionals Conducted audits of Manufacturing Facility to ensure compliance with CGMP, Corporate and site SOPs Provide QA support to Manufacturing for clinical and commercial batches.
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Companies Worked For:
TPS Associates, Incorporated
Hampton Forge LTD
American Intercontinental University
Job Titles Held:
Quality Assurance Inspector
Quality Assurance Manager
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
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