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Qc Manager Resume

New, YorK

SUMMARY:

  • I have successfully led Chemistry and Microbiology Departments in the area of product quality, product release, timely delivery, global cross - functional team collaborations, customer and supplier relationship management, program and project management, technical support, problem solving, OOS investigations, lab supply and standard (API) purchases, equipment purchasing/qualification/validation/calibration (Master Plan, PM Service and 21 CFR Part 11, 210 & 211), supply quality, method development/validation/transfers, product transfers, stability programs, data trend analysis, quality system management (Empower, LIMS, SAP), SOP and technical report writing/reviewing/amendment/approval, documentation (CTD), regulatory compliance and inspections with Confidential, OSHA, EPA and Health Canada, employee hiring/development/training/performance reviews/disciplines, risk management and process continuing improvements in order to meet global drug development and manufacturing needs (pharmaceutical, dietary supplements, cosmetics, Rx, OTC, consumer products and API).
  • Moreover, I have in-depth knowledge of sourcing strategies and risk mitigation from planning, budgeting, vendor selections, due diligence, negotiations, cost optimization/reduction, quality consistency, supply capacity, lead time, competitiveness, leverage, value added relationship management, alliances, effective communication, culture ramification management to political and economic instability and currency fluctuation surveillance.
  • As a result-driven manager and effective leader, I assign the right people to the right positions, provide guidance to drive high productivity, and build strong relationships with cross-functional team leaders to resolve complex issues and to facilitate the process. As a global citizen, I hold MS and MBA (honor student). And I can lead a diverse team with winning strategies to meet the organizational goals on the global stage.

COMPUTER AND INSTRUMENT PROFICIENCY:

Microsoft software: Advanced Excel, Word, PowerPoint, Outlook, Lotus Notes, Project, Adobe Acrobat

Other software: Empower, LIMS, QDIS, ERP, SAP, Visual, M-File, ARIBA, TEDI, EDMS, Track-Wise

Instruments: HPLC/UV-VIS, PDA, UPLC, GC, LC/MS, GC/MS, LCP/MS, UV Spectrophotometry, TLC, KF, FTIR, Polarimeter, TOC, DSC, Particle-size Analyzer, ELISA Kits, Gel-Electrophoresis, Balance, Advanced Bio-sample Analyzers, etc.

PROFESSIONAL EXPERIENCE:

Confidential, New York

QC Manager

Responsibilities:

  • Oversaw Chemistry and Microbiology Department activities for raw material, in-process control and finished product analysis and release with UPLC/MS, HPLC, GC, LCP/MS, UV, TLC, FTIR & Cytometry techniques
  • Provided resolutions and collaborated with cross-functional team leaders and Senior Management to improve product quality and the business process in order to meet short-term and long-term business goals
  • Prioritized workloads and testing schedules to meet customer and manufacturing requirements
  • Assigned right tasks to the right employees
  • Oversaw laboratory equipment, chemical and standard purchases
  • Provided training on GMPs, safety, method development/improvement and lab equipment (e.g. HPLC, GC)
  • Led or delegated qualified employees for deviations or OOS/OOT investigations
  • Oversaw product assay testing at contract laboratories (e.g. Covance)
  • Implemented LIMS system for the quality operation
  • Took a lead during the Confidential, NSF and other third-party inspections from preparation, walk-through, closing-bell to follow-up and CAPA activities; supervised Standard Purchasing program to meet Confidential requirements
  • Worked with QA and Compliance to revise laboratory SOPs and specifications
  • Managed customer complaints due to product quality and timely delivery issues
  • Ensured that lab instrumentation is properly qualified per GMP requirements (Master Plan, PM Service)
  • Worked with HR for employee hiring, retaining, development, performance reviews and disciplines

Confidential

Managing Director

Responsibilities:

  • We provide a range of consulting services including: market research, problem solving, strategic sourcing and process improvement for quality, drug development and manufacturing in (bio-) pharmaceutical industry

Confidential, New York

Director of Business Development

Responsibilities:

  • Assisted president and consultants with the strategies to improve customer service and increase market share to serve healthcare and pharmaceutical industries

Confidential, New York

Sr. Scientist, Technical Support

Responsibilities:

  • Coordinated with R&D, IT, QC, Stability, Compliance, Purchasing, Engineering and Production to facilitate the method development, validation and transfer process and to support global drug manufacturing
  • Worked with global suppliers/CMOs and cross-functional teams to help evaluate and solve complex issues
  • Troubleshot routine and non-routine technical problems and provided resolutions
  • Purchased chemicals, STD (API) and other laboratory supplies regularly through ARIBA system and vendors
  • Coordinated instrument qualification, repair and quality system maintenance
  • Provided guidance and training to scientists on analytical methods, quality systems and instruments
  • Performed assay, impurity, dissolution, ID, water content tests with HPLC, UPLC, GC, UV, Dissolution Bath, KF and TLC for method development, method validation and transfers
  • Reviewed and approved analytical results in notebooks and Empower/LIMS systems for product release
  • Coordinated with IT and QA for new software and product specification set-ups as an Empower power-user
  • Collaborated with Compliance for SOP reviewing and approvals to support NDA filling & change control
  • Took a lead for lab and full-scale OOS investigations
  • Authored cleaning validation methods, method transfer and investigation reports

Confidential, New Jersey

R&D Analytical Chemist

Responsibilities:

  • Performed stability analysis for formulation screening and product release to support regulatory submissions
  • Developed and validated analytical methods with HPLC/UV-VIS and HPLC/PDA instruments
  • Participated in Confidential regulatory inspections

Confidential, New York

Process Manager/ Scientist

Responsibilities:

  • Coordinated with cross-functional teams and established a GMP testing lab for chemical and analytical R&D
  • Purchased HPLC, GC & other instruments, raw materials, chemicals, reagents and other laboratory supplies
  • Supervised lab equipment installation, qualification, repair and maintenance
  • Managed quality, safety programs and vendor/CMO relationships to drive continuous improvement
  • Trouble-shot and provided solutions for routine and non-routine technical issues
  • Provided guidance to employees on analytical methods, quality systems and instruments
  • Ensured adequate training to be provided and motivated employees for high productivity
  • Developed and validated analytical methods with HPLC, GC and LC/MS, and authored analytical methods
  • Coordinated with IT for quality system upgrades and maintenance
  • Reviewed and approved analytical results in notebooks, Millennium and LIMS systems for product release
  • Ensured budgets, schedules, and performance to meet departmental goals
  • Ensured employee safety and environmental compliance as a member of safety committee
  • Participated in internal and external regulatory inspections and CAPA

Confidential

Analyst

Responsibilities:

  • Performed QC and Stability analyses for assay, impurity, content uniformity and dissolution testing by using HPLC/UV-VIS and GC instruments to support drug manufacturing
  • Reviewed and approved analytical results in notebooks, Millennium and LIMS systems for product release
  • Trouble-shot for resolutions
  • Purchased lab supplies when needed
  • Provided guidance to junior Analysts

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