QC Tech II

Job Description Summary

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule.

Essential Functions

• Performs in process testing for internal customers.
• Performs finished goods, returned goods, and stability testing for external customers as needed.
• Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
• Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.
• Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system.
• Troubleshoots and performs routine maintenance on laboratory instrumentation.
• Prepares all standards and reagents needed for proper execution of analytical methods and procedures.
• Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy.

Department Specific/Non-Essential Functions

• Assists in any non-routine analytical work needed to solve plant problems.
• Works on solving problems and implementing improvements in a teaming environment.
• Uses problem solving skills to help with failure investigations and testing problems.
• Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
• Assists with training others as needed.
• Other duties as assigned with or without accommodation.

Minimum Requirements

Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree.

Experience: 1 – 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus.

Expected Skills/Qualifications: Must be able to perform basic mathematical calculations. Familiarity with basic laboratory procedures, equipment, and computer key punching. Sound and correct technical judgments are required during routine analysis. High degree of concentration is required. Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). Functional/Technical Skills, Priority Setting, Written Communication, Customer Focus, Organizing.