Quality Tech II

Job Title

Quality Tech II

Requisition

JR000014779 Quality Tech II (Open)

Location

Raleigh, NC

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

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.  This position will be on a rotating schedule.

ESSENTIAL FUNCTIONS:

• Performs in process testing for our internal customers.
• Performs finished goods, returned goods, and stability testing for our 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 and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Other duties as assigned with or without accommodation.
• 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.

MINIMUM REQUIREMENTS:

Education:

Associate degree or Technical degree in a related degree required.

B.S. degree in Physical Science or related field preferred.

Experience:

1 – 3 years laboratory experience in a pharmaceutical manufacturing operation.

Working knowledge of cGMP required.

Preferred Skills/Qualifications:

Other Skills/Competencies:

Ability to read and write effectively.

Must be able to perform basic mathematical calculation.

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.

Functional/Technical Skills, Priority Setting, Written Communication

Customer Focus, Organizing

RELATIONSHIP WITH OTHERS/ SCOPE:

• 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 fast changing of priorities are necessary to complete assigned tasks.  Laboratory employees must be able to work effectively under these conditions.
• Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities.  No supervisory responsibilities are assigned to Quality Tech II, but they provide examples of proper techniques in training new employees as assigned.
• 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.

WORKING CONDITIONS:

• Most work is performed in a modern, well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments.
• Sampling is performed in a warehouse or in the processing area.  Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
• Exposure to fugitive emissions of chemicals typical for chemical operations.
• Normal dexterity is required for routine handling of laboratory glassware and instruments.  Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished.
• Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position.
• Must be able to work a 12 hour shift schedule of day shift (7am -7pm), to off period, to rotating night shift (7pm -7am). In addition to occasional overtime as needed.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.