Michael Pilkinton Email & Phone Number

Concord, North Carolina, United States

Shreveport, La

Assess risk for active products on-site, including Nitrosamine Impurity Assessments encompassing API, excipients, and packaging components; process flow evaluation; cleaning procedures; and purified water systems.Continually ensure that the site maintains its Quality Management System (QMS) encompassing process performance; quality monitoring, CAPA, and change management systems; and product audit reviews.KEY ACCOMPLISHMENTS:• Collaborate with internal and / or external agencies to perform and / or host audits.• Expertly assist the QA Labor Control Department in reviewing and approving components.• Review and approve Annual Product Reviews and Continued Process Verifications (CPVs), as well as contribute skill in the use of Minitab software for statistical analysis of product trending.• Successfully review and approve IQ / OQ / PQ protocols, equipment qualifications, Standard Operating Procedures (SOPs), and calibration reviews for all on-site departments.

Shreveport, La

Leveraged broad scope of industry knowledge toward performing raw material, API, in-process, finished product, and stability analytical testing and data review for targeted commercial release and stability studies.Drove protocol writing, execution, and review for new instrumentation IQ, OQ, and PQ, and new product test method validations. Procured material and equipment for new product test methods and instrumentation.Managed a top-performing team of eight (8) analysts for analytical method validation and batch testing for new product launches. Planned and coordinated daily workflow to meet all critical deadlines and ANDA filings.Collaborated among departments (e.g., administration, manufacturing, quality assurance, planning, project management, technical, R&D) for new projects, and site / procedural improvements, and cost-saving efforts.KEY ACCOMPLISHMENTS:• Strictly adhered to cGMP, GLP, GDP, and data integrity policies.• Led change control initiation for SOPs, specs, and method creation / revisions.• Authored OOS and OOT incident reports to identify root cause for failures and CAPAs.• Exhibited talent with analytical method transfers, validations, and USP monograph verifications.• Recognized as Subject Matter Expert (SME) for new site products and employee qualifications.

Bossier City, La

Demonstrated proven experience in maximizing the success of HVAC, electrical, paint, general construction, and plumbing departments. Cost-effectively ordered and replaced HVAC filters for parish-specific schools.

Bossier City, La

Optimized accuracy-focused inventory management by assessing stock-on-hand and reconciling discrepancies. Led a details-centric team in continually driving on-site operational productivity and efficiency.