QC Tech II

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

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.

Job Description

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:

Other Skills/Competencies:

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). If testing criteria are not met with

uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them.

Functional/Technical Skills, Priority Setting, Written Communication

Customer Focus, Organizing

RELATIONSHIP WITH OTHERS/ SCOPE:

• Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities. 
• Majority of work is performed independently without direct supervision.  Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel.
• Reports to Quality Testing and Release Manager.
• Frequent interact with operators, engineers, and Quality management for reporting routine analytical results.  Communication may be though radio, telephone, email, or in person.
• Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers.
• Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes.
• Ability to understand the timely nature of work, quick reporting of results, and