QC Tech II

Job Description Summary

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.

• 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 control samples and reports results 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 the Mallinckrodt record‑keeping 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.

• 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 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.

• Education:
  
  Associate of Science (AS) or Bachelor of Science (BS) or equivalent life‑science degree preferred (appropriate experience may replace a degree).
• Experience:
  
  1–3 years laboratory experience in a pharmaceutical manufacturing operation preferred; working knowledge of cGMP is a plus.
• 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 color‑blindness test (e.g., Ishihara). If testing criteria are not met with uncorrected vision, color‑correcting glasses may be used as long as criteria are met while using them.
• Functional/Technical skills, priority setting, written communication, customer focus, organizing.
• Relationship with others / Scope:
  Laboratory technicians communicate any uncompleted work to the next shift and 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 appropriate management personnel. Reports to Quality Testing and Release Manager.

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 outside the laboratory and may require lifting and transporting to the laboratory area. Exposure to fugitive emissions of chemicals typical for chemical operations is possible. Normal dexterity is required for routine handling of laboratory glassware and instruments;

colors must be well‑visualized and slight differences in liquid volumes in appropriate glassware distinguished. Must wear 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. Must work a rotating 12‑hour shift schedule (7pm‑7am / 7am‑7pm) and occasional overtime as needed.

The above statements are intended to describe the general nature and level of work being…