QC Chemistry Supervisor Resume Example
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QC CHEMISTRY SUPERVISOR
Summary
Result-focused pharmaceutical professional with strengths in management, problem solving and continuous improvement. Proactive leader with strengths in communication and collaboration. Proficient in leveraging cGMP and compliance knowledge to promote laboratory excellence. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes.
Skills
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Laboratory Equipment/Software Experiance
HPLC, GPC, GC, UV-Vis Spectroscopy, Particle Size Distribution, Karl Fisher Titration (volumetric), SampleManager 10, SLIM (Stability Lab Information Manager), Empower3, JMP 13, Smartsheet, Microsoft Office, Trackwise, Waters Nugenesis ELN and SDMS, Adobe Acrobat Pro, WebEx, Veeva Document Management System
Experience
QC Chemistry Supervisor / Danaher - El Dorado Hills , CA08/2018 - Current
- Provided general management and guidance to ensure cGMP, company policies and regulations were met at all times
- Guided auditors from regulatory agencies and corporate partners through the QC Laboratories
- Author, reviewer and approver of numerous procedures, studies and reports
- Collaborated with multiple departments to ensure timely release of finished product
- Performed nearly all laboratory investigations pertaining to the team's products ranging from Minor to Major severity
- Member of several site project teams to ensure Quality Control was represented and contributed to company goals
- Contributed to the qualification of new bulk and fill lines
- Worked closely with corporate partners to ensure consistency of testing and timely release of finished product
- Organized several method transfers to other countries as the transferring site
- Audited external sites for compliance and consistent testing practices
- Primary author of a major revision of the global laboratory investigation SOP which addressed compliance risks
- Revised the analytical data trending process by creating a site specific SOP the encompassed all departments
- Provided compendia reviews and implemented changes for several pharmacopoeias including USP-NF, EP, JP and ChP
- Primary point of contact for corporate partner's laboratory for both chemical and microbiological testing
- Authored numerous change controls involving multiple departments, sites and corporate partners
- Continued to perform analytical testing when needed to meet sample release deadlines
QC Analyst II / Danaher - Fargo , ND02/2017 - 08/2018
- Performed and reviewed Finished Product analyses
- Proficient in GC and HPLC Analysis
- Experienced in Alkermes Change Control process and execution
- Presented information gathered from leadership courses at the University of Dayton
- Attended “Lab of the Future Consortium” to discuss the future of laboratory planning with many industry leaders
- Performed and generated investigation plans for numerous laboratory investigations for both internal and external customers
- Adept at using Trackwise to create and complete deviations
- Regular QC representative at site planning meetings
- Provided analytical expertise for a critical investigation
QC Analyst I / Bristol Myers Squibb - Asheville , NC02/2016 - 02/2017
- Responsible for maintaining and improving the Stability Program.
- Responsibilities included weekly stability pulls, creating and updating stability protocols as well as stability reports.
- Worked with controlled substances in the Stability Program including Samidorphan and Buprenorphine.
- Involved in site project teams to support company growth
- Lead and was a part of several audits including DEA audits
- Completed change controls in order to change validated systems
- Created and Implemented stability tracking tools to help the lab schedule stability testing, stability set downs and forecasting
QC Analyst / Aerotech - City , STATE05/2015 - 02/2016
- Responsible for maintaining the Stability Program
- Contributed time to other miscellaneous tasks, primarily in the QC department (APR's, Equipment Files)
- Lead a partner audit of the stability program
- Participated in a DEA Audit
- Completed change controls tasks in order to change validated systems
- Very familiar with multiple products on site in terms of testing requirements and expected results
- Aided in laboratory investigations
- Compiled data for regulatory requests for both this site and for partner organizations
- Experienced in working with multiple groups from multiple departments
Education and Training
University Of Dayton - City, State12/2019Supervisory Leadership Certificate
- 10-day leadership development program
- Developed critical skills necessary to maximize individual and team performance.
Miami University - City, State05/2015Bachelor of Arts: Chemistry
- Undergraduate Research - The focus of the research is to use Co(II) as a spectroscopic probe in proteins.
- 4 year athlete - Lacrosse
William Mason High School - City, State06/2011High School Diploma
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Resume Overview
School Attended
- University Of Dayton
- Miami University
- William Mason High School
Job Titles Held:
- QC Chemistry Supervisor
- QC Analyst II
- QC Analyst I
- QC Analyst
Degrees
- University Of Dayton -
City,
State
12/2019 Supervisory Leadership Certificate
Miami University - City, State 05/2015 Bachelor of Arts : Chemistry
William Mason High School - City, State 06/2011 High School Diploma
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