Excel
Troy Manchester O’Henry
Chemist
Pflugerville,TX
Summary
Methodical Quality Control Analyst skilled in developing protocols to positively impact manufacturing quality. Practiced at completing exhaustive tests of incoming materials, components and finished products. Proven experience within pharmaceutical industry performing direct hands-on work in QA, QC, and R&D functions with strong familiarity of general practices. A strong self-motivator and driven researcher, this organized and dependable candidate has been successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
Work History
QC Associate
Luminex
2023.11 - Current
- Leads and assists in the investigation, resolution, and reporting of findings impacting Reagent QC initiated through audits, non-conformance reports, CAPAs, or customer complaints
- Delivers timely and accurate Quality Control testing results for bioassays, stability studies, continuous improvement studies, and core consumable products, along with all proper documentation. Prepares and verifies Reagent Certificates of Quality
- Schedules timely outsource testing and services with associated documentation of results
- Documents non-conformances and participate in Material Review Board as required
- Responds appropriately to environmental monitoring notifications of specialized storage areas; includes being on a 24/7 call list rotation
- Assists in the cleanliness and integrity of QC laboratory and storage areas through proactive application of 5S practices
- Assists in monitoring of departmental supplies and stocking of focused Reagent QC supplies; generates Purchase Orders as needed.
- Performs equipment calibration checks regularly to uphold accurate measurements during testing procedures.
QC Chemistry Analyst
ICU Medical
2023.05 - 2023.10
- Performed non-research chemical science work utilizing GMP techniques, which included HPLC/GC (using Empower 3 software), titrant assays, polarimetry, flame photometry to ensure the Quality Control of factory product batches; prepared reagents and manufactory samples
- Conducted in-depth research on emerging trends in analytical chemistry, applying findings to improve laboratory procedures.
- Improved laboratory efficiency by streamlining sample analysis processes and implementing new techniques.
- QA/QC and acceptance testing of reagents in accordance with the Company’s SOP and Quality Assurance plan
- Collected, processed, and analyzed internal laboratory samples for QA/QC and contamination monitoring
- Maintained chain-of-custody
- Decontamination of workspaces, including hoods/air boxes, equipment, and other items associated with processing and analysis activities
- Disposed of bio-hazardous waste
- Interpreted results of assays and reports findings to relevant departments
- Data entry utilizing computerized or computer-linked systems
- Performed routine equipment calibration, cleaning, assembly, and maintenance
- Restocked and maintained proper inventory of necessary supplies.
Associate Scientist
Extractables and Leachables, PPD
2021.05 - 2023.05
- Independently performed a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing
- Routinely worked on analytical method development & validation for extractables and leachables methods
- Trained on routine operation, maintenance and theory of analytical instrumentation (GC & HPLC analyses), SOPs and regulatory procedures and guidelines
- Problem solved with assistance pertaining to extraction and/or instrumentation problems
- Managed QC/QA responsibilities without supervisor or QA input; drafted Quality Events and Deviations independently and submitted for QA approval within deadlines
- Communicated project status to project leader
- Reviewed, interpreted, and analyzed data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
- Performed self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
- Operated as a founding member of Extractables & Leachables 5S Committee, ensuring compliance of departmental resources and work areas with GMP and safety guidelines.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Conducted experiments in laboratory environment for product development purposes.
Research Lab Coordinator
PPD
2020.09 - 2021.05
- Audited Blood Harvest Logs to confirm that all study samples were handled correctly per protocol specifications and/or PPD procedures
- Reviewed logs for clerical errors and accordance with ALCOA-C quality standards
- Verified and documented the presence of all blood and urine samples as each study interval ended
- Maintained records of completed temperature and maintenance checks for all laboratory equipment
- Performed all duties of a blood harvester, blood runner, and urine processor as needed
- Acted as Lab liaison on studies as directed by supervisor and independently
- Interacted with Study Teams, Project Managers and other non-lab staff to assure that protocol requirements for the lab are being followed
- Occasionally communicated with clients, explaining the various PK lab functions and activities
- Ensured safety requirements and GLP standards were adhered to when handling and processing samples
- Packed and Shipped specimens to clients and/or other labs as needed, ensuring safety and security per PPD policies and other safety regulations
- Rectified equipment and supply needs
- Oversaw the technicians in the blood and urine areas assuring smooth and efficient workflow
- Minimized the occurrence of protocol violations via preventive thinking
- Observed laboratory standards and practices, identified areas for improvement, and made recommendations for alternative systems to improve quality and efficiency
Research Lab Technician
PPD
2019.07 - 2020.09
- Collected and harvested required laboratory specimens (blood plasma, serum, etc.) as required by lab SOP and client parameters
- Monitored procedure timeliness whilst participating in studies requiring blood draws for multiple subjects & timepoints
- Completed all required study documentation in congruence with ALCOA-C quality standards
- Assured all procedures were done according to GLP and processing areas are maintained in a uniform, clean, and organized fashion
- Mentored new employees applying communication and positive work ethic for an optimal team workflow
Education
Bachelor of Science - Behavioral Neuroscience
St. Edward’s University
Austin, TXSkills
Method Development and Validation, with emphasis in Extractables and Leachables
Accomplishments
- Supervised team of ~20 staff members in a clinical laboratory setting, often with only one other supervisor, while collectively processing high volumes of biosamples and related assays.
- Documented and resolved numerous scientific investigations, coordinating with management and QA which led to the accurate documentation and re-testing of a valuable client products, maintaining our deliverables timelines and positive Company relationship with stakeholders.
- Achieved the preservation of hundreds of thousands of dollars in biological testing samples through effectively helping with emergency damage mitigation during the Texas Winter Blackouts of 2021, voluntarily staying on site for an excess of 30 hours continuously while coordinating with management trapped offsite.
- Facilitated institutional change in PPD's Extractables and Leachables team by volunteering to found and formalize a departmental 5S Committee with management's approval and guidance.
Software
Word
SPSS
Empower 3
Chromeleon
Veeva Quality Docs
Interests
Community Service
Conservationism
Independent Research & Grant Writing
Timeline
QC Associate
Luminex
2023.11 - Current
QC Chemistry Analyst
ICU Medical
2023.05 - 2023.10
Associate Scientist
Extractables and Leachables, PPD
2021.05 - 2023.05
Research Lab Coordinator
PPD
2020.09 - 2021.05
Research Lab Technician
PPD
2019.07 - 2020.09
Bachelor of Science - Behavioral Neuroscience
St. Edward’s University
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