Job Description

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

OF POSITION:
The Quality Technician IV is responsible for performing comprehensive analysis and inspection of finished goods, in-process materials, and raw materials using chemical, physical, and instrumental methods to ensure compliance with established quality standards. In addition to core testing responsibilities, this role actively supports broader Quality Control laboratory operations to maintain continuous workflow, regulatory compliance, and operational excellence.

A critical function of the Quality Technician IV is serving as the primary trainer and subject matter resource for new and developing team members. This includes leading onboarding efforts, delivering structured and hands-on training, ensuring adherence to standard operating procedures (SOPs), and fostering technical competency across the team. The role is expected to proactively mentor, coach, and assess trainee performance, reinforcing best practices, safety standards, and quality expectations to build a highly capable and consistent workforce.

The Quality Technician IV may work a rotating or day shift schedule, with responsibilities tailored to operational needs; however, ownership of training excellence, knowledge transfer, and team capability development remains a central expectation across all assignments.

ESSENTIAL FUNCTIONS

Rotating Assignment:

• Ability to proficiently perform all functions of a Quality Technician III.
• Must be completely trained and proficient in all rotating areas of the QC Lab, i.e., PAP Controls, APAP Controls Lab, and Finished Lot testing.
• Performs in process testing for internal customers.
• Performs finished goods and stability testing for external customers.
• Performs sampling and testing on all raw materials as assigned.
• Assists with preparing and shipment of hazardous and non-hazardous samples for the QC laboratory.
• Assists with QC Lab Hazardous Waste program.
• Stocks laboratory chemicals and helps with checking inventory levels for ordering needs.
• Assists QA as needed.
• Performs specified analysis on all process control samples and all finished goods and reports results in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
• Maintains accurate and precise records of all laboratory analysis using LIMS and written documentation. Demonstrates superb documentation skills as a qualified documentation reviewer.
• Troubleshoots and performs routine maintenance on laboratory instrumentation. Takes ownership of continued education regarding instrument maintenance and troubleshooting.
• Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively trains others in a positive manner.
• Acts as a leader in the laboratory. Point of contact for plant and QC/QA management. Ensures that the lab runs smoothly and all required testing is being addressed assigning tasks appropriately according to technician training.

ESSENTIAL FUNCTIONS

Day Shift Assignment:

• Must be completely trained and proficient in all Raw Material testing. Able to peer review all QC laboratory testing.
• Performs sampling and testing on all raw materials as assigned. Act as primary reviewer/releaser of raw materials.
• Performs specified analysis on all process control samples and all finished goods and reports results in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
• May perform in process testing, finished goods, stability, or special analysis testing as requested.
• Manages logbook issuance and filing.
• Manages sieve pan program.
• Coordinates QC Lab Hazardous Waste program.
• Ensures laboratory supplies and chemical stock is sufficient by monitoring inventory, ordering materials, and unloading stock.
• Submits and tracks purchase requisitions for the QC laboratory. Reviews spending on a monthly basis, escalating special purchases or items that may impact budgeting.
• Coordinates periodic water and environmental testing, including scheduling external contractors for sampling and analysis.
• Utilizes Quality Management Systems to record and investigate OOS and Exceptions.
• Performs periodic reviews of Quality Control documents (SOPs, Work Instructions, Methods) and complete Change Controls to implement updates.
• Performs preparation and shipment of hazardous and non-hazardous samples for the QC laboratory.
• Assists other QC team members and QA as needed.
• Maintains accurate and precise records of all laboratory analysis using LIMS and written documentation. Demonstrates superb documentation skills as a qualified documentation reviewer.
• Troubleshoots and performs routine maintenance on laboratory instrumentation. Takes ownership of continued education regarding instrument maintenance and troubleshooting.
• Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively trains others in a positive manner.
• Acts as a leader in the laboratory. Point of contact for plant and QC/QA management. Ensures that the lab runs smoothly and all required testing is being addressed assigning tasks appropriately according to technician training.

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 team environment.
• Performs any quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
• Demonstrates advanced problem solving skills to analyze and complete failure investigations and testing problems.
• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
• Demonstrates the ability to work independently, stay focused, and use time wisely.
• Participates in customer audits and Lab tours.
• Takes ownership of own training and uses opportunities effectively to learn new testing.
• Completes all required Compliance trainings in a timely manner.

MINIMUM REQUIREMENTS

Education:

Associates of Science (AS) or Bachelors of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree.

Experience:

Rotating Assignment Minimum 5 years QC Lab experience, trained and competent in all areas, i.e., PAP Controls, APAP Controls Lab, and Finished Lot testing.

Day Shift Assignment Minimum 5 years QC/QA experience or closely related field. Experience with Mallinckrodt QC Laboratory and testing is preferred.

Working knowledge of cGMP required.

Preferred Skills/Qualifications:

Other Skills/Competencies:

Must demonstrate advanced problem solving skills as well as leadership skills.

Must be able to comprehend and independently carry out written procedures, record results and observations, and perform mathematical calculations.

Requires familiarity with all laboratory procedures and equipment and an understanding of instrument operation.

Must have an understanding of chemical properties, like molecular weight, molecular formula, and basic reactions to prepare volumetric solutions and standards.

Sound and correct technical judgments re required during routine analysis.

Strong computer skills.

Functional/Technical Skills, Priority Setting, Written Communication

Customer Focus, Organization

RELATIONSHIP WITH OTHERS/ SCOPE:

• Reports to Quality Control Supervisor (Rotating) or Quality Control Manager (Day Shift).
• Frequent interactions 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. Inability to work with set priorities can result in process delays and/or missed shipping commitments.
• 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. Non-routine results, observations, or analytical requests are to be brought to the attention of appropriate management personnel.
• Able to work independently without direct supervision. No direct supervisory responsibilities are assigned, but they do provide examples of proper technique in training new employees as needed and may assign tasks to other technicians as needed.

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. Some sampling is performed in a sample booth or in the processing 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, goggles, face shield, and other equipment as deemed necessary by EH&S, corporate, or safety guidelines for the position.
• Rotating Assignment: A rotating 12 hour shift schedule of (7pm-7am / 7am-7pm). Overtime may be required/requested.
• Day shift Assignment: A day shift schedule of (8 hours / M-F). Overtime may be required/requested.

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.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides 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.