Amanda Diehl
Mitchell,IN
Summary
Experienced in pharmaceutical manufacturing with expertise in Batch Records and FDA guidelines. Eager to contribute to team success through hard work, attention to detail, and strong organizational skills. Motivated to continue learning and growing in the industry, while leading my team to success daily.
Overview
23
23
years of professional experience
Work History
Room Lead, Drug Product, Secondary Manufacturing
Catalent (formerly Cook Pharmica)
01.2014 - Current
- Inspected product and materials for defects following a strict reject criterion
- Created defects to use for machine qualifications and testing
- Reviewed documentation for accuracy and compliance on all batch records following cGDPs
- Created and reviewed logbooks for particle sets and cosmetic defects
- Identified, labeled, and packaged samples
- Properly handled materials and product to ensure safety of both equipment and personnel.
- Lead teams to meet daily production targets
- Coordinated personnel and executed batch record instructions
Operator, Finishing/Packaging
Baxter BioPharma Solutions
01.2003 - 01.2008
- Bulk and machine packaged final product
- Set up production lines
- Reviewed batch records to ensure cGDPs were met
Education
High School Diploma - undefined
Mitchell High School
Mitchell, IN01.2000
Skills
- Pharmaceutical SOP compliance
- Familiarity with cGMPs and cGDPs
- Experienced with pharma manufacturing
- Worked with a diverse team in a collaborative environment
- Reviewed Logbooks and Batch Record for accuracy and corrections
- Familiar with FDA guidelines and CFRs
- Good at multi-tasking in a fast paced, production environment
Timeline
Room Lead, Drug Product, Secondary Manufacturing
Catalent (formerly Cook Pharmica)
01.2014 - Current
Operator, Finishing/Packaging
Baxter BioPharma Solutions
01.2003 - 01.2008
High School Diploma - undefined
Mitchell High School
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