Quality Specialist

TALENT Software Services

Wilson, NC

12 Months

Key Responsibilities

• Routine laboratory testing of incoming components such as HDPE bottles, foils, films, plastic caps, etc.
• Entering data into Labware.
• Participation in investigations.
• Participating in root cause analysis sessions.
• Occasional minimal troubleshooting of instrumentation issues.
• Participation in the daily tier process.

Testing Equipment

• Calipers
• Magna Mike
• FTIR
• Balances

Requirements & Tech Stack

• Good knowledge of GMP documentation.
• Good team mindset.
• Ability to quickly learn new processes, procedures, and equipment for testing / reviewing components.
• Working knowledge of SAP.
• Working knowledge in the use of GLIMS.
• Experience using calipers and table top scribers.
• Experience using an FTIR.
• Familiar with ANSI sampling plans and how to apply them.
• Good technical writing skills for revising procedures and writing quality notifications.
• Some experience in audit scenarios (internal and agency audits).

Qualifications

• B.A./B.S. degree (Science or Engineering)
• Associate degree with 3 years pharmaceutical experience
• High school diploma with 5 years pharmaceutical experience

Preferred Skills

• One year of pharmaceutical industry experience.