As Director of the Quality Assurance Department, I was responsible for all of the duties noted in the Coordinator position as well as the added responsibilities, which came with the title, of Director of Quality Assurance of which I was promoted to in 2014. As Director I was responsible for implementing and overseeing that the agency was delivering quality services to the individuals served, as well as ensuring all guidelines, policies and regulations put forth by the overseeing entities were followed by the staff as well as the agency. Responsible for agency wide incident management. Worked closely with OPWDD and the New York State Justice Center, which was initiated in 2013. Navigated multiple computer systems put forth by SullivanArc, OPWDD and the NYS Justice Center On call for the entire SullivanArc agency 24-7 with regard to Incident management. Supervised Quality Assurance Department Dealt with the local police departments as well as the State Police when situations warranted that support. Worked closely with sister agencies throughout Orange and Sullivan Counties. Formulating recommendations daily, to departments within the agency, focusing on better programming and continued safety for the individuals served. Ensuring that all recommendations given were followed through by management. Resource to all departments within the entire SullivanArc agency.
- Director of Quality Assurance at SullivanARC
- Quality Assurance Coordinator at Corporate Compliance
- Office Clerk at Architects Office at John C. Horton
- Homemaker at Circleville Elementary
8 years, 9 months at this Job
- Bachelor of Arts - Communications
Director of Quality Assurance for aseptic biosimilar production from clinical to commercial stage. Review raw material and production releases, including assessment and control of CMOs for laboratory and manufacturing functions. Responsible for review and approval of site and external investigations, change control, and training. Regulatory responsibility for reviewing BLA (biologic licensing application). Current tasks also include responses to FDA for PAI outcomes, as well as information requests (IR) from the agency as they pertain to BLA submission.
- Director of Quality Assurance at Adello Biologics
- Senior Director, Quality at Alcami
- Director of Quality Assurance at Morton Grove/Wockhardt Pharmaceuticals
- Site Quality Manager at Vertellus Specialty Materials
10 months at this Job
- B.S. - Chemistry
- Ph.D. - Organic Chemistry
10/2017 - Present Arrow's ability to manufacture gearing products, which are capable of meeting the most demanding customer requirements, has created an extensive and diverse list of customers - supplying both aerospace and commercial applications. Director of Quality Assurance Created an AS9100D and NADCAP complaint quality system, Empowered Employees and Satisfied Customers in a Union environment for both commercial and government Customers. Created CSI:AGC. Launched site-wide Gemba Huddles. Streamlined inspection. Raised all Customer scorecards to Green or Gold. 60% reduction in nonconformances and 10% increase in revenue Year / Year.
- Director of Quality Assurance at Arrow Gear Company
- Director of Quality at Valid USA
- Director of Quality at Rexnord Aerospace
- Manufacturing Engineering and Quality Leader (Director) - Systems at GE Aviation
1 year, 3 months at this Job
- Master of Science - Information Systems
- Bachelor of Science - Business Administration & Urban Studies
- Associate of Science - Electronics
Design, develop and implement systems in all areas of food safety and quality.
• Providing food safety, quality, regulatory compliance and business operations continuity to food manufacturing facilities
• Overall responsibility to lead facility in compliance towards certification in third party audit requirements (i.e. systems in all areas of food safety and quality in a food manufacturing environment
• Have worked with a variety of food categories such as sandwiches, salads, yogurt parfaits, airline catering, frozen Mexican (meat/poultry), waffles, pancakes, muffins, nutrition bars, rice, grains, beans, nuts, pet food, superfoods including nuts and fruits, chocolates/confectionaries, produce (fruits/vegetable), retail food stores, etc.
• Led facilities into GFSI (SQF or BRC) certifications or re-certifications, trained employees on FSMA and PCQI, guided through recall protocols, assisted in business startups and expansions
- Director of Quality Assurance at INDEPENDENT CONSULTING FOOD SAFETY & QUALITY
- Director of Quality Assurance at VAN'S NATURAL FOODS
- Quality Assurance Manager at FOSTER FARMS
- Quality Assurance Manager at FLYING FOOD GROUP
6 years, 11 months at this Job
- Master's - Business Administration
- Associate in Science - Biology
- Bachelor of Arts - Political Science
Implement a comprehensive quality assurance program for a 3000 member/125 staff Care
• Monitor and improve quality of client care, identify and standardize best practices, and assure ongoing compliance with regulatory requirements.
• Draft operational policies and procedures, in cooperation with other members of the management team. Ensure that policies are in compliance with government agency regulations and lead Health Home policies.
• Identify training needs and support training interventions to meet quality standards, including coordination and delivery of monthly Compliance Trainings.
• Participate in NADAP's Corporate Compliance Committee and represent NADAP at external meetings.
• Perform regular audits and other quality assurance activities on client charts in both NADAP's Health Home Database and lead Health Homes' electronic health records to monitor client care.
• Respond to external regulators, including developing and executing on Corrective Action Plans.
• Oversee implementation of contract with Healthix, including project management of the technical buildout, development of policies, and training staff.
• Liaise with pro bono counsel DLA Piper and The Lawyer's Alliance on legal issues relating to HIPAA, HITECH, CFR part 42, and state law compliance.
• Develop reporting functionality for the Corporate Compliance Committee, and evaluate privacy violations for reportability. Investigate data and privacy breaches, propose and oversee corrective actions.
• Implemented a comprehensive staff onboarding system for setting up access to multiple clinical databases (HCS, MAPP, Healthix, PSYCKES, Epaces, UASNY) ensuring that access is enabled and terminated in a timely and organized manner.
- Director of Quality Assurance at NADAP-Health Home Care Coordination
- Program Director at CUCS-Delta Manor Shelter
- Program Director at CUCS-Crotona Park East
- Program Director at CUCS
3 years, 3 months at this Job
- MSW - Rehabilitation Counseling
- BA - Linguistics
- MSW - Clinical Social Work
Cuisine Innovations Unlimited, LLC | 180 Lehigh Avenue Lakewood, NJ
Director of Quality Assurance for two plants 6/2015 - Present
• Ensure that vendor compliance information is updated according to BRC regulations.
• Conduct inspection of processes.
• Conduct numerous facility audits.
• Ensure that GMP's are being performed and documented.
• Ensure that new products meet USDA standards.
• Submit USDA Applications.
• HACCP Certified.
• Seafood HACCP Certified
• PCQI, Preventive Controls Training
• Passed BRC Audit with Grade A at both facilities.
• Passed Organic Audit 100% compliance.
• Kosher Certified.
• Halal Cerified.
• Passed Gluten Free Audit 100% compliance.
• Esha Research (Genesis) Certificate.
• Internal Audit Certificate.
• Create and implement HACCP plans.
• Verify that information on BRC logs is updated on a daily basis.
• Perform and document internal audits and report results to management.
• Perform quality inspections on ingredient statements, nutritional information, and cooking directions on all products.
• Create ingredient and nutritional statements in Genesis.
• Create labels for products using Label View version 2014.
• Respond to customer service/complaints.
• Submit Micro samples to Laboratory.
• Responsible for Sanitation Department.
• Maintain purchase order information.
- Director of Quality Assurance for two plants at The Fillo Factory
- Quality Assurance Inspector at Broadridge Financial Solutions
- Quality Assurance Inspector at Doma Technologies
- Sales Associate/Customer Service at Doma Technologies
3 years, 7 months at this Job
MEMS factory for biomedical devices and other industries)
• In charge of all quality assurance activities
• Implementation of ISO 9001:2015 from scratch
- Director of Quality Assurance at Rogue Valley Microdevices
- Vice President of QHSE at ION Geophysical
- Vice President of Quality Assurance at The VMC Group
- Director of Quality, North America Operations at Essilor of America
3 years at this Job
- Master of Arts in Management - Information Technology
- Bachelor of Science in Business and Management - Business and Management
- Associate of Science in Quality Technology - Quality Technology
Established a quality assurance department consisting of hardware/software test, configuration management, quality inspectors (i.e. production, suppliers, RMAs), and reliability engineering. Manage budget, resources, and schedules.
• Establish Quality Management System (QMS) in effort to secure AS9100D/ISO9001 Certification.
• Established product quality strategies (i.e. internal/external audits, continuous improvement initiatives, inspections and conformity, processes and verification, supplier quality).
• Mentor and direct QA Department personnel in achieving quality goals and ensure evidence of compliance to AS9100 processes.
• Developed processes supporting optimization of product quality through development and implementation of automated testing of software products via Jira, Bitbucket, and Bamboo, as well as definition of production processes, verification, and sign-off.
• Oversee quality of the U.S. Air Force Remote Visual Assessment (RVA) video surveillance system (depot and field maintenance) sustainment program and RVA II upgrade contract as part of the U.S. Intercontinental Ballistic Missile sites located throughout the West/Midwest United States.
- Director of Quality Assurance at Sentry View Systems
- Engineering Quality Manager at ALSTOM
- Independent Consultant at Independent Consultant
- President/Founder at Fine Industries Corporation
1 year, 2 months at this Job
- Bachelor of Science - Computer Science
Management, Leadership, and Coaching of an international team of Quality Assurance personnel for a top-performing company in the Conferencing Industry. - Ensured timely delivery of Quality Assurance testing of internal and external facing software applications - Successfully implemented metrics gathering and reporting strategies to improve overall code quality. - Implemented Automated testing frameworks, procedures, and strategies in the the organization causing a reduction in regression testing cycle time and improved release night timelines/success rates. - Redefined SDLC and other internal processes to optimize productivity and communications between development and quality assurance teams.
- Director of Quality Assurance at PGi
- Director/Manager of Business Analysis, Quality Assurance, Software Support, Business Application Support at ACT Conferencing
- Connected Services Program Manager at Sun Microsystems
- Business Development Manager at Sun Microsystems
2 years at this Job
- Certificate - Entrepreneurship
- MBA - Business
- BA - Communications
• Direct supervisor to Quality Assurance Coordinator and Quality Assurance Validator.
• Created and reconstructed the Quality Assurance Department for the agency.
• Created QA Plan for 6 residential Group Homes and 2 Adult Training Centers.
• Ensure training of all employees on Fee for Service (FFS) and Medicaid documentation through the electronic health portal (THERAP).
• First Aid and CPR trainer for agency. Conduct monthly trainings to ensure compliance throughout agency.
• Conduct daily and monthly inspections of programs using QA plan tools to ensure compliance.
• Monthly reports written and submitted to Executive Director with corrective action plan attached.
• Staff training (CDS administrator) and team building at monthly staff meetings.
• Staff recruitment and staff retention plans.
• Responsible for creation and completion of any UIR reports to the State of NJ.
- DIRECTOR OF QUALITY ASSURANCE at ALLEGRO ADULT SERVICES
- COMMUNITY LIVING DIRECTOR/GROUP HOME MANAGER at CENTER FOR HUMANISTIC CHANGE
- DIRECTOR OF RESIDENTAL SERVICES at HUDSON MILESTONES
- YOUTH COUNSELOR at INNER HARBOUR
4 months at this Job
- High School Diploma