SUMMARY:

Collaborative consultant emphasizing computer, quality and laboratory systems in a GMP environment. Comprehensive background in laboratory and quality systems. Self - motivated, innovative and goal-oriented professional committed to exceeding customer expectations. Committed to collaborating with clients to completing the targeted work timely and accurately.

SKILL:

• Project management
• Self-motivated
• Strong verbal and written communication
• Process oriented
• Conflict resolution
• Process implementation
• Root cause analysis
• ICH Q9 Subject matter expert
• ICH Q2 Subject matter expert
• ICH Q3D Subject matter expert
• Computer System Validation and Data Integrity (GAMP 5) Subject matter expert
• Highly skilled technical writer (Validation protocols, reports, SOP’s, analytical methods, test scripts, etc.)
• Effective at writing and managing change controls and CAPA’s
• Raw material and product specification development
• Drafted Standard Operating Procedures
• Patient at performing on software applications and chemistry techniques
• Instruments Qualifications: HPLC (UV, PDA, RI & CD), GC (FID & TCD), ICP M/S, GC M/S, FTIR, RAMAN, NIR, Autotitrator and Particle Size Analyzer Method Development and Validation/Verification: Assay, Impurities, Dissolution, KF, Reaction Completion and USP/EP/JP Monograph and General Chapters.
• Software Profiency: Labware, Trackwise, MasterControl, Documentum, GxPharma, TotalChrom (TurboChrom), Empower 2 & 3, Chromeleon, Chemstation, DataPro2, OMNIC, Tiamo, Agilent Dissolution Workstations, LabX, Oracle, SAP, Microsoft Project, Microsoft Office (Word, Excel, Powerpoint and Access)
• Experienced and respectful of a diverse workforce
• Respectful of department and company policies
• Develop subordinates to increase technical and interpersonal skills
• ASQ Certified Pharmaceutical GMP Professional (CPGP) No. 594
• ASQ Certified Software Quality Engineer (CSQE) No. 6271
• Courses in C++ and VBA

WORK EXPERIENCE:

Confidential

Quality Systems Project Manager

Responsibilities:

• Reported to Director of Corporate Quality and Regulatory Services
• Supervise LIMS/Empower administrator and two method validation chemists.
• Developed and managed a project to implement ICH Q3D Elemental Impurities for API manufacturer with 50+ customers in 68 countries. 10% of product portfolio originated from natural sources such as Calcium Carbonate, Sodium Carbonate and Dolomitic Lime. Implemented new cost-effective controls that protected product sales but not affecting customer formulation or regulatory filings.
• Developed and managed analytical method remediation project to upgrade method validations to meet ICH Q2.
• Lead CSV and data integrity project for 4 sites to comply with 21 CFR part 11, EMEA Annex 11 and FDA Guidance on Data Integrity. Planned and executed on 21 laboratory applications including LIMS and Empower.
• Resolved product shelf life issue for high valued product with minimal impact to customer regulatory filings. Solution was expanded to increase shelf life of multiple products of similar form.
• Lead multiple FMEA projects to identify necessary facility upgrades to improve product quality, operator safety and customer confidence. Each upgrade resulted in solutions in the range of $900k- $2.2M in upgrades for API and Vaccine Adjuvant manufacturing.
• Collaborated with business units for cost model analysis. Analyzed cost of quality of product lines by determining direct and indirect costs including labor and supplies.
• Reported project metrics to management which includes the site leadership team, corporate VP's and CXO's.

Confidential, VA

Quality Control Planner

Responsibilities:

• Reported to QC Director
• Established standard labor times for all test methods and developed work schedule based on available labor and sample priority
• Prioritized work for Supervisors and Managers to ensure customer satisfaction.
• Oversaw test scheduling for raw material, in-process, finished product, stability and technical services testing for 40 chemists by collaborating with QC supervisors to prioritize work based on supply chain and compliance deadlines.
• Member of Intra-department Project Management Team for New Product
• Introductions (NPI).
• Drafted protocols and reports for dose dumping studies based on FDA draft guidance's.
• Oversaw testing of brand and generic samples for preparation of bio-study.
• Worked with Regulatory Affairs to ensure all analytical requirements were complete on time for studies.
• Developed method transfer, Process Validation testing and CV method development schedule to meet NPI timelines.
• Coordinated with Regulatory Affairs closely to ensure any method revisions did not negatively impact NPI.
• Tracked productivity and compliance metrics for the laboratory and report to site and corporate quality groups.
• Represented QC in site planning meetings to ensure QC readiness.
• Wrote, evaluated, and reviewed departmental deviations, investigations, and CAPAs and ensure remediation and assessment maintain compliance to company and regulatory standards
• Managed 5 technical writers that conducted work completing deviations, investigations, change controls and CAPA's.
• Member of LEAN team to reduce non-value added activities, implement Visual Management Boards, in corporate 5S into laboratory culture, developed standard testing times for scheduling, analyst utilization tracking.
• Adjusted testing strategies to be able to support testing loads of to the laboratory.
• Developed and managed an automation effort to increase productivity as labor resources were reduced.
• Continuously identified ways to increase productivity, reduce cycle times through reduction in labor loads.
• Reviewed and approved test scripts for laboratory applications.

Analytical Services Supervisor

Confidential

Responsibilities:

• Reported to QC Manager
• Managed team of 7 chemists that conducted method development, transfers, verification and validation of drug substance, drug product and cleaning validation
• Managed method transfers from 4 sites due to commercial site consolidation and new product launches
• Managed and solved technical problems with methods new to laboratory
• Managed process validation sample testing
• Managed 6 QC Laboratory Auditors that reviewed QC testing
• Improved process by implementing metrics collection without adding work to the auditing process

Analytical Services Senior Chemist

Confidential

Responsibilities:

• Reported to QC Manager.
• Conducted method transfers on drug substance and drug product methods.
• Developed methods for cleaning validation.
• Optimized existing test methods for better performance often by making minor changes to diluent composition, column, mobile phase pH, etc.
• Supported process validation testing.
• Provided analytical guidance for investigations.

Confidential, Springfield, MO

QC Supervisor

Responsibilities:

• Reported to QC Manager
• Oversaw daily operations of 24/7 QC laboratory.
• Qualified and maintained all laboratory instruments. Resolved any downtime immediately.
• LIMS Administrator (SAP Quality Module).
• Conducted material approvals in SAP.
• Addressed any personnel issues promptly, discreetly and professionally.
• Escalated safety and quality issues and initiated remedial actions promptly.
• Inspected laboratory daily for cGMP compliance.
• Collaborated with QA to improve compliance and address any gaps from customer and internal audits.

Analytical Development Chemist

Confidential

Responsibilities:

• Reported to QC Supervisor
• Worked with Senior Principal Analytical Chemist to develop and validate analytical methods
• Supported process development chemists and pilot plant for new product development
• Qualified Primary and Secondary Standards
• Trained QC chemists on new methods and supported any instrumentation issues

QC Laboratory Analyst

Confidential

Responsibilities:

• Reported to QC Supervisor
• Entry level shift chemist performing routine testing on raw materials, in-process, finished product and stability of specialty intermediates, API precursor and API
• Laboratory operations were 3 shift, 7 days per week.
• Performed method development, method validation, pilot scale support and process validation.
• Became proficient in Wet chemistry, HPLC (UV and Conductivity), GC (FID and TCD), FTIR, UV/VIS and GC M/S.