Quality Assurance Specialist Dedicated and knowledgeable Quality Assurance Specialist with leadership and training experience. Adept at quality control of commercial and investigation research and development areas within the pharmaceutical industry. Delivers in-depth competencies within cGMP, GMP, CGP, DEA and FDA regulated environments. Posses extensive experience in packaging and manufacturing protocols, including medical, electronic, batch recipes, batch records issuance/reviews and incident/deviation internal and external audits. Expertly writes Standard Operating Procedures and constructs key reports. Offers bilingual capabilities in English and Spanish Additional core competencies include: Quality Assurance Leadership / Training GMP / GLP FDA / DEA Regulations POMS Systems / Inventory Data Analysis Protocol Reviews Auditing Communication Manufacturing Research and Development Packaging
QA Clinical Packaging Department QA Clinical Manufacturing Department
QUALITY ASSURANCE MANAGER March 2016 to May 2016NBTY － Bayport, NY
Responsible for implementing and enforcing the compliance of the quality systems in place.
Work in partnerships with other departments to ensure processes are aligned with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs), as well as other state and federal agencies.
Maintained a close schedule of internal and external audits as required.
Maintain a stystem of Deviations/Investigations and CAPAs related to to the processes carry out in house.
Manage and monitoring the daily quality activities on the production floor for three shifts.
Participated in quality improvement teams to reduce defects and quality issues, and other projects required by management.
Monitored daily quality activities of the Quality team Suporting the 3 shifts Lead quality training program for all levels of the company Identified issues affecting efficiencies and develop solutions to presented challenges Lead and monitor the internal GMP audit program Lead and monitor and support the on-time closure of assigned deviations and CAPA Reported weekly and Monthly Quality metrics to Leadership tem Kept accurate employee records; file proper reports (accident, probation, etc) Managed, and coached associates on a regular basis and as needed Supported the Quality team members to ensure products and processes comply with the relevant requirements of the quality management system Monitored the compliance of processes and associated records to company standard operating procedure requirements and work closely with operations and R&D if changes are necessary.
QUALITY ASSURANCE DOCUMENTATION SPECIALIST January 2014 to March 2016Citation Clinical Labeling Systems － Hauppauge, NY
Perform all functions concerning the generation (authoring), management and maintenance of all types of technical documents generated by the company, as well as performing the required training on new and / or updated critical documents for the processes of production, inspection and distribution of finished products.
Oversee the process of Change Control chain ensuring documents get routed, reviewed and approved within stipulated time frame.
Participate in internal departmental audits as well as outside vendor audits.
Conducted training for new employees as they get hire, and prepare and execute Annual GMP review across the entire company.
Generate electronic database to organize SOP documents in different categories for a better tracking of current, documents, documents with pending reviews and updates, and obsolete documents.
Perform SOP review for all documents based on a 2 year review plan.
Perform GAP reviews on SOPs to bring all documents to a stage of compliance of documents and processes.
Write SOPs on different processes as required, update current documents based on actual processes and practices.
Participates on the review process of customer complaints received and the answer to those complaints based on complaints investigation founding's.
Participate in the generation, review and approval of internal (plan) / external (unplanned) deviations generated as required.
Maintain and update training records for all departments, and carried out special projects overseeing vendor processes of production for various products.
Facilitate training for new employees, training to existing personnel based on new / SOP updates, as well as the Annual GMP review across the company.
QUALITY ASSURANCE ASSOCIATE IV January 2006 to January 2014Forest Research Institute, Inc － Hauppauge, NY
Performed medical and production packaging protocol reviews and approvals, including the review and approval of distribution diagram protocols.
Carried out the review and approval of unexecuted/executed production packaging batch records, labeling protocols, electronic batch recipes, and final product releases.
Reviewed and approved equipment PQs, and performed audits on clinical study reconciliations.
Performed the review and approval of master label copies created in label view, and ClinPro systems to be utilized in CTM.
Executed incident/deviation reporting/review and approval via Trackwise.
Performed audits on clinical study reconciliations, and reviewed/approved equipment cleaning verification proposals.
Maintained and updated training records for the QA group, and carried out special projects overseeing vendor processes of production for various products.
Created and implemented QA agreements between the company and outsourced vendors.
Collaborated to ensure the success of pre-approval inspections at production facilities.
Reduced the number of in-process checks required to comply with the allotted amount of production inspections.
Collaborated within a 21-month assignment focused on the review and approval of production manufacturing master batch records, production manufacturing electronics recipes, and the issuance of unexecuted production batch records.
Reviewed and approved equipment calibration and periodic maintenance equipment reports.
Executed incident / deviation reporting / review and approval via the Trackwise system.
Conducted special assignments and project operations abroad for Clinical Trial Materials at an international depot, ensuring consistency with concurrent stability projects.
Collaborated with various departments and co-workers on different projects affecting the quality department.
Reviewed executed production batch records as well as product specifications and Certificate of Analysis for product release manufactured in the corporate facility.
Performed departmental system and procedural audits to ensure compliance with regulatory agencies and company policies.
QUALITY ASSURANCE SUPERVISOR January 2004 to January 2005A&Z Pharmaceuticals － Hauppauge, NY
Managed and scheduled production assignments for eight quality assurance technicians providing QA support in the areas of manufacturing and packaging.
Organized, maintained and executed packaging batch records and supportive documentation required for the final release of finished products to be distributed.
Reviewed and monitored staff attendance and punctuality, and facilitated new staff GMP training.
Determined and allocated human resources on a daily basis to support last-minute mandated production operations.
Implemented CAPAs based on customer complaint investigations and procedural audit recommendations.
Managed and implemented GMP training and development programs for the production packaging and QA departments.
Revised, updated and organized Standard Operating Procedures (SOPs) for the packaging and manufacturing departments to ensure compliance with corporate standards and FDA guidelines.
Flawlessly organized monthly audits for various company divisions, including maintained labeling inventory control, packaged retained samples area and packaging component specifications.
QUALITY ASSURANCE TECHNICIAN / PACKAGING OPERATOR January 1999 to January 2003DuPont Pharmaceuticals Co. / Bristol Myers & Squibb － Garden City, NY
Expertly conducted procedural and system audits, executing CAPAs based on audit findings.
Performed batch audits to ensure the accuracy of information documented, and allocated material and human resources to production jobs.
Led and facilitated training sessions to improve technical skills, raise safety awareness and conduct reviews of federal regulations as related to the pharmaceutical industry.
Carried out small training sessions with co-workers on the use of the inventory control system BPCS and ROPICS, and the importance of practicing FIFO and tracking materials inventory used.
Conducted safety meetings for the packaging department focusing on safety inspections performed and proposing ways of correcting problems found.
B.B.A : Business Computer Information Systems Business ManagementHofstra University － Hempstead, NYBusiness Computer Information Systems Business Management
A.S : Engineering Drafting Design Construction ManagementOklahoma State University － Okmulgee, OKEngineering Drafting Design Construction Management Training: Quality Management System Software (Trackwise); Production and Operation Management System; Inventory Management Control (Clinpack); Business Planning and Control System (BPCS)
Auxiliary Police Officer (1995-2008)