QA Spec
- 1. DAVID L. LITTLE 38 Ethan Allen Dr. Palm Coast, Florida 32164 (812) 734-4977 3littles@sbcglobal.net www.linkedin.com/in/davidlittle2 QUALIFICATIONS SUMMARY Quality Control/Quality Assurance Professional with extensive years’ experience in Pharmaceutical manufacturing. Held various positions in the quality department, including testing & inspecting packaging components, auditing packaging lines, perform purge audits, processing areas, review packaging & processing records. Supervise 10-20 people performing redress/rework operations both on, and off-site. Lab testing (wet chemistry) on finished product. Loyal, dedicated, and ambitious with a drive to succeed in challenging environments. Self-directed, as well as team oriented. Performs well under pressure, while maintaining high focus on detail and quality. Exceeds expectations while meeting deadlines; excellent time management skills. Strong organizational, and communication skills, along with a great attention to detail. Computer Skills: Microsoft Word/Excel, SAP, LIM’s, Trackwise, Maximo and Internet research. PROFESSIONAL/EMPLOYMENT EXPERIENCE SABIC INNOVATIVE PLASTICS 12/2011 - 03/2015 CERTIFIED FORMULATION TECHNICIAN, MOUNT VERNON, IN Responsible for weighing and formulating batches of chemicals(powders), and introducing to blenders to produce batches of resin powder to be made into pellets. Clean blenders, and surge hoppers per prescribed procedures. Stage material for use on lines, and bins. Transfer powder from silos, and bins by computer. COOK PHARMICA LLC 6/2011 - 12/2011 Quality Assurance Specialist, Bloomington, IN Worked in secondary packaging area by reviewing processes, Standard Operating Procedures (SOPs), validation protocols, review/approve change controls, approve CAPA’s in Trackwise, perform pre & post approval of work orders for accuracy, and compliance to cGMPs in Maximo. Review batch records, pull AQL samples for inspection per procedures, and FDA regulations. BRISTOL-MYERS SQUIBB COMPANY 1976 – 2009
- 2. Quality Documentation Specialist, Mt. Vernon, IN (1999 – 2009) Responsible for reviewing processing and packaging records for accuracy and completeness, ensuring compliance according to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs). Validated processes against current work practices and ensured documentation was up to date and complete, facilitating efficient operations. Issued COA’s (Certificate of Analysis) / COC’s (Certificates of Compliance), and Certification Letters to Sister Sites and 3rd party manufacturers for approved materials. Performed purge audits and sign off on packaging lines ensuring no leftover product or components were left on line from previous run. Released approved bulk for use in packaging; released approved finished goods to distribution centers. QC Packaging Specialist, Mt. Vernon, IN (1998 – 1999) Responsible for inspecting, testing, and releasing packaging components for pharmaceutical production. Audited third party manufacturers’ finished goods. Over-seen/supervise redress operations Ensured procedure and cGMP compliance in audits of packaging lines. QC/QA Inspector and Auditor, Buffalo, NY (1976 – 1998) Responsible for pharmaceutical product consistency through inspection and testing of packaging components and raw materials. Served as Quality representative for vendor and third party manufacturing problem resolution. Over-see/supervise both on-site, and off-site redress operations. Audited packaging and blow-molding lines ensuring regulatory and cGMP compliance. Monitored validation process to ensure compliance across functions and departments. ACHIEVMENTS Improved release times to within 24 hours of final pack date on assigned product , saving an average of one million dollars in late charges per day. Member of Continuous Improvement team producing $600,000 in annual savings by reducing waste in powder filtering process. Key member of Buffalo project team to move entire production line in-house from third party manufacturer. Researched and implemented new validation requirements for T-Stat w/pads, as directed by FDA. Validated all packaging equipment (including Filler, Torquer, Car Toner, and Induction Sealer). Wrote all operational and installation protocols. Performed all qualification testing. Chosen to assist in alleviating backlog in Stability Testing department - one year assignment (988-1989), achieving a 97.6 lab testing efficiency rating. Performed line equipment validations as Quality representative on numerous project teams. Identified on several occasions incorrect labeling of chemicals preventing several thousands of dollars in mis-formulations, and not meeting customer delivery dates. Served on safety team, and identified unsafe practices of cleaning blenders, and implemented scheduled PM’s to equipment to prevent toxic fumes escaping in work flow areas. Volunteered to cross over in other areas of quality area to help relieve backlog.
- 3. EDUCATION BRYANT & STRATTON COLLEGE, Buffalo, NY Marketing and Sales, 1984 – 2000 SPECIAL TRAINING Total Quality Management (TQM), 1996 Training sessions included: How to Conduct Meetings Team Building Problem Solving Techniques Benchmark Writing Course, 1992 Accepting Change, 1997 BenAstrum Pharma Broad Technical Web Seminar for “The Batch Record Process and Investigation of Discrepancies, Compliance, Training and Management”, 2008 COMMUNITYAFFILIATIONS LITTLE LEAGUE: Basketball Coach, Soccer & Flag Football Coach, Mt. Vernon, IN, 1998 – 2003 INDIANA HIGH SCHOOL BASKETBALL, Officiated, 1998 – 2000 MUSCULAR DYSTROPHY SOCIETY (MDS), Buffalo, NY, 1991 – 1994 Organized fund raisers and raised donations Bristol-Myers Squibb Volunteer of the Year, 1992 CITY MISSION, Buffalo, NY Organized fund raising golf tournament for Frank Reich (Buffalo Bill’s quarterback), 1992 – 1995 NEW YORK HIGH SCHOOL & WOMENS COLLEGE BASKETBALL, Officiated 1976 – 1998