Laura Kerekes
Syracuse,NY
Summary
Motivational leader and organizational problem-solver with advanced supervisory, team building and customer service skills. Experience stepping into roles and quickly making positive changes to drive company success. Decisive and disciplined professional with a quality-driven mindset. Maintains detailed, current records with diligent attention to detail, while upholding Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Looking to put expertise and experience to good use in a permanent role with a forward-thinking company.
Overview
11
11
years of professional experience
Work History
Laboratory Manager
Norwich Pharmaceuticals/Alvogen
Norwich, NY
05.2013 - Current
- Working as a Laboratory Manager overseeing the documentation scientists; StarLims; raw material, packaging component, microbiology, and finished product/stability testing groups
- Duties: In charge of developing employees; evaluating employees; developing and updating SOP’s; developing and updating test methods; writing method verification/validation protocols and reports; handling audits by commercial customers and regulatory agencies including the MHRA and FDA; monthly and yearly budgets; OOS/OOT investigations; developing and completing CAPAs and action items; compendial review committee member; reviewing specification updates.
Quality Technician IV
Covidien-Mallinckrodt
Hobart, NY
- 05.2013
- Worked as a Quality Technician IV doing peer review; material release; raw material and packaging component testing specification development/update; SOP development/update; exception/CAPA/OOS investigations; managing the Compendial Change Review Committee; developing and implementing continuous improvement projects; monthly trending of environmental monitoring data; developing method verification/ transfer protocols; manage change control system for raw materials laboratory.
Lab Technician
Graham Laboratories
Hobart, NY
- Worked as a Lab Technician sampling and testing various pharmaceutical raw materials API and excipients using: HPLC, GC, IR, UV/Vis, TLC plates, Titrations, Karl Fischer Water Titrator, RoTap/Air Jet, pH meter, Ashing Furnace, TOC analyzer, Polarimeter, Melting Point Apparatus
- Promoted to a Senior Lab Technician doing advanced analyses, trouble shooting, and instrument calibration
- Promoted to Assistant Supervisor doing peer review, testing specification development/update, and SOP development/update.
Raw Materials Laboratory Supervisor
Mallinckrodt Pharmaceuticals
Hobart, NY
- Worked as the Raw Materials Laboratory Supervisor managing a group of 6-8 employees
- Duties: In charge of testing and release of raw materials and packaging components in the manufacture of solid dose and liquid pharmaceuticals; interviewing/hiring/training of employees; scheduling work; developing employees; evaluating employees; coordinating facility water system testing; developing and maintaining the environmental monitoring program; developing and updating SOP’s, developing and updating test methods
- Handled audits by commercial customers and regulatory agencies including the MHRA and FDA; monthly and yearly budgets; safety audits and training; OOS investigation, exception investigations; developing and completing CAPA action items.
Education
Bachelor of Science - Biochemistry
Elmira College
01.1986
Skills
- Able to prioritize tasks and work with a sense of urgency to ensure that assignments are complete and timely
- Experienced using Microsoft Office/Word/Excel/PowerPoint, MiniTab, JMP, QUMAS, SAP
- Training: Facilitation Skills; Behavioral Interviewing; Getting Things Done – Managing Workflow, Projects and Priorities; Core Interactive Skills; Managing Change; Coaching for Success; Coaching for Improvement; Conflict Resolution; People Skills; Situational Leadership; StarLims
- Experienced in investigational/problem solving tools: Kepner-Tregoe, Fishbone Diagram, 5 Why’s, Kaizen
- Proficient in USP/NF, European Pharmacopeia, Industry Standards, GMP, cGMP
- Developed ANSI based sampling plans
- Assisted in developing and implementing a vendor certification program
- Assisted in developing and maintaining the Approved Supplier File/List and Supplier Corrective Action Request (SCAR) system
- Method Verification/Validation
- Performing and writing Laboratory Investigation Reports
Timeline
Laboratory Manager
Norwich Pharmaceuticals/Alvogen
05.2013 - Current
Quality Technician IV
Covidien-Mallinckrodt
- 05.2013
Lab Technician
Graham Laboratories
Raw Materials Laboratory Supervisor
Mallinckrodt Pharmaceuticals
Bachelor of Science - Biochemistry
Elmira College
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