Quality Lab Chemistry
Resume:
Mark Nix
Statesville, NC ***** Cell: 828-***-**** advjmz@r.postjobfree.com
PROFESSIONAL SUMMARY
A company's success comes from people who think and do. In doing both I have been able to successfully supervise and develop the laboratories assigned to me. I firmly believe leading by action is a vital trait for a person's success, as well as flexibility and adaptability. I am an analytical minded chemist with extensive experience in quality laboratory control including regulations and compliance with FDA, EU, GDP, and cGMP. With over 15 years of professional experience in chemical laboratories in diversified areas and roles, I am highly familiar with modern chemical laboratory equipment needed to execute successful operations and have mastered preventative maintenance for a variety of instruments. Additionally, I am proficient in maintaining data integrity which is crucial in operations today. Strong supervisor and organizational skills have given me the tools to manage and train teams of chemists, and I always look for ways to better myself and my team. I have vast experience working efficiently in a swift moving, high pressure environment.
SKILLS
• Data integrity
• Laboratory Quality Assurance
• CPR/AED
• OSHA/EHS
• Proficiency with computer system: Word, Excel, Trackwise, Maximo, AS400, and many instrument user program
• Instrumentation: troubleshooting, repair, calibration and preventative maintenance WORK HISTORY at BAXTER HAEALTHCARE Marion, NC
Analytical Support- 08/2019 - Current
• Chemistry training system.
• Instrument calibration.
• Instrument preventative maintenance and repairs.
• Laboratory purchasing support.
• Laboratory investigations and NCR/CAPA.
• Laboratory supervision support.
Interim Receiving and Inspection Supervisor- 03/2019 - 08/2019
• Appointed as supervisor of R&I during colleague’s leave of absence.
• Review and approve documentation for Raw Material Lab and R & I. Special Projects/Weekend General Lab Supervisor- 07/2017 - 03/2019
• Generate and present metrics to Senior Leadership Team, SLT. Prepare data sheets with charts as power point to include in Quarterly Management Review, QMR.
• Supporting, writing and implementation of corrective action preventative action, CAPAs.
• Support and participate in all internal and external audits. Prepare and present audit findings.
• During the weekends, supervised Initials, Finals, Raw Materials labs as well as R & I. Initial/In Process and Raw Materials Laboratories; QLA III, Lab Supervisor- 05/2015 - 07/2017 Mark Nix
449 Oakhurst Road
Statesville, NC 28677 Cell: 828-***-**** advjmz@r.postjobfree.com
• Manage preparations of instrumental testing required for all drug codes, per daily schedule.
• Plan Chemistry Lab testing according to instrumentation limits and reagent availability.
• Initiate and complete Defective Material Reports. Objective and timely investigation of OOS result of chemical testing, Raw Material non-conformances and procedural errors.
• Proficient in FIFO accountability. Initiate, investigate and implement SCARS.
• Coordinate scheduling, testing and releasing of Raw Materials that are part of pre-delivery program.
• Communicate with other Baxter facilities concerning critical testing required for continued production.
• Maintain Lot Monitor System for materials which qualify for reduced chemical testing.
• Verify all data within the Certificate of Analysis confirming all products conform to regulation.
• Oversight in supplier and regulatory quality audits. Receiving and Inspection; Quality Lab Associate III, Lab Supervisor- 04/2013 - 05/2015
• Meet with suppliers during visits to Baxter North Cove.
• Manage 4 quality tech analysts.
• Plan and prioritize daily activities according to production and scheduling needs.
• Part of team responsible for approval of changes of specifications used globally.
• Participate in supplier audits and regulatory quality audits. Initial/In Process Laboratory; Quality Lab Associate II, Lead Chemist-04/2010 - 04/2013
• Testing and proper documentation of all Initial analysis samples via HPLC, UV/Vis, AA, Flame, Photometer, Polarimeter, Colorimeter, Osmometer and general wet chemistry techniques.
• Testing of In-process, code change, and absence of drug samples.
• Collaboration with leads and supervisors for preparation of all necessary testing of drug codes.
• Use of POMS Weigh/Mix, BLIMS, MMS II, AS400, Maximo Service Request.
• Involvement with the validation of PAT system and continued involvement with the use, maintenance and problem solving of this system.
• Approval of Batch paperwork Initials lab related SOPs. Raw Materials Laboratory; Quality Lab Associate II, Lead Chemist-05/2009 - 04/2010
• Testing and proper documentation of Raw Material samples via HPLC, UV/Vis, AA, Titrino, Polarimetry and other wet chemistry techniques.
• Collaboration with Scheduling Department, lab leads, supervisors and R&I to ensure testing schedules were met for any raw materials used in daily production schedule.
• Proficient in instrument calibration and maintenance within Raw Materials Lab. Initial/In Process Laboratory; Quality Lab Associate I- 05/2005 - 04/2009
• Conduct chemical analyses on Initial, In-process samples.
• Collect and record data needed to ensure quality control.
• Execute audits in laboratory and mixing areas.
• Perform instrument maintenance within the initial analysis lab. North Iredell High School Physical Science and Environmental Science Teacher- Olin, NC 08/2003 - 05/2005 EDUCATION
Mark Nix
449 Oakhurst Road
Statesville, NC 28677 Cell: 828-***-**** advjmz@r.postjobfree.com Bachelor of Science: Environmental Biology 05/2000 Francis Marion University - Florence, SC ACHIEVEMENTS
• Laboratory Chemical Hygiene Officer
• Multiple Annual Performance Ratings of Exceeds
• EHS Ergonomics group Kiazan including individual project recognized on global Baxter EHS website, 2011
• Recognized by SLT for Extra Mile Award
• Recognized by QLP for Individual Achievement Award in 2009
• Received Super Co-Worker Certificate in 2007
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