Lauren McGhan
Bloomington,IN
Summary
Detail-oriented Quality Control Senior Scientist with over 17 years of experience working in a CDMO environment. Well-versed in qualitative and quantitative analysis techniques, specifically focused in Raw Material testing. Skilled in collaborating with management in order to meet quick and ever changing deadlines. Proven experience within the pharmaceutical industry while committed to performing quality work while remaining complaint with federal, state and cGMP regulations.
Overview
18
18
years of professional experience
Work History
QC Senior Scientist
Catalent Pharma Solutions
11.2006 - Current
- Created, built, implemented, and maintain database of over 500 chemicals and solutions for all raw material testing performed. Conduct monthly audits to ensure database is accurate and up to date
- Provide mentorship and aid in onboarding of incoming analysts to establish baseline expectation of standards required to perform testing with emphasis on quality and good documentation practices
- Maintains scheduling board while collaborating with other groups to meet changing deadlines
- Supports method transfer work by assisting in complex methods being transferred into the facility
- Simultaneously manages a heavy workload, while meeting all pertinent deadlines
- Continuing to establish a comprehensive knowledge of a variety of testing including: ELISA, Assays; indicator and potentiometric, Dot Blot, Protein Concentration, Bead based immunoassays, as well as an all inclusive knowledge of all major compendias
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidance
- Maintains the necessary compliance status required by company and facility standards.
Quality Lab Associate II
Baxter Biopharma Solutions
09.2006 - 11.2011
- Provided support to the raw material, finished product, and stability of pharmaceuticals by analysis of chemical and biological assays for quality of product by compliance and efficiency
- Gained skillful knowledge of analytical instrument usage including: FTIR, TOC, UV-Vis, Karl-Fischer, Polarimeter,, Osmometer, and various other instrumentation
- Performed a number of biological assays including: SDS-PAGE, Western Blot, Slot Blot, and Ouchterlony double immunodiffusion
- Specialized in a variety of compendial testing from the USP, EP, and Japanese Pharmacopeias
- Qualified to write laboratory invesitgation reports, and level one and level two exception reports
- Conducted quarterly audits to ensure proper documentation as well as maintain correct storage of laboratory documents and worksheets.
Education
Bachelor of Science - Biology, Minor in Chemistry
Indiana University Bloomington
Bloomington, IN2006
Skills
- Experienced and highly motivated professional
- Proper planning, coordination and multitasking abilities that enable deadlines to be met well in advance
- Exemplary record in performing high level testing with utmost proficiency
- Extensive analytical and organizational skills
- Capability to perform thorough research in order to evaluate policies and procedures
- Equal ability to work independently and as a positive team member
- Broad-based knowledge in Microsoft Office (Word, Excel, Powerpoint)
- Experienced with Laboratory Information Management Systems (LIMS) software, Trackwise, Sharepoint, EDMS
Timeline
QC Senior Scientist
Catalent Pharma Solutions
11.2006 - Current
Quality Lab Associate II
Baxter Biopharma Solutions
09.2006 - 11.2011
Bachelor of Science - Biology, Minor in Chemistry
Indiana University Bloomington