QC Tech II

About the Role

Analyzes process samples as received and performs non-routine analysis as requested. Analyzes finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. Typically works 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

Additional Responsibilities

• 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

Qualifications

Associate 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

Required Skills

• 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

Working Relationships

• 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 interaction with operators, engineers, and Quality management for reporting routine analytical results. Communication may be through 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
• Completes all required Compliance trainings in a timely manner

Working Conditions

• Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments
• 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 rotating 12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed