QC Tech II

Paladin Labs Inc.; Raleigh (NC); On-site; USD 40,000 - 60,000; Full time

Job summary

Paladin Labs Inc. is looking for a Quality Tech II in Raleigh, North Carolina. This role involves analyzing process samples and finished goods, performing routine and non-routine analyses, and maintaining accurate records using the Mallinckrodt record-keeping system.

The ideal candidate should have an AS or BS in life-science, possess 1-3 years of relevant experience, and be capable of working independently on a rotating shift schedule. Familiarity with cGMP is preferred.

Qualifications

• 1-3 years of laboratory experience in a pharmaceutical setting preferred.
• Working knowledge of cGMP is a plus.
• Ability to work independently without direct supervision.

Responsibilities

• Analyze process samples and finished goods.
• Perform routine and non-routine analyses.
• Maintain accurate records of laboratory analysis.

Skills

Basic mathematical calculations

Familiarity with laboratory procedures

Technical judgment

Color differentiation

Education

Associate of Science (AS) or Bachelor of Science (BS)

Tools

Analytical instruments

Laboratory glassware

Job description

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.

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 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.

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 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: 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.

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 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.

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, or skills required of employees assigned to this position.

EEO Statement

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state, or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.