Technician, Quality Control Instrument

USPL NUTRITIONALS LLC

North Brunswick, NJ

Expired: 23 days ago Applications are no longer accepted.

Full-Time

Job Description

Technician, Quality Control Instruments - 04.16.2024.pdf

Job Description

Date

04/2024

Location

1200 Airport Road, North Brunswick NJ

Title

Technician, Quality Control Instruments

Department

Quality Control

Reports to

Manager, Quality Control Documentation

FLSA (Exempt or Non-Exempt

Non-Exempt

Role Overview

The Quality Control Instruments Technician Responsibilities include but are not limited to: Support QC Instruments & Equipment(s) for QC Stability, QC Micro and QC Analytical functions. Perform in-house calibrations and certifications as per SOP and published / manufacturer provided manual. Perform monitoring of all EMS alerts and alarms to ensure the environmental systems recording temperature and/or relative humidity are within specified ranges and operating systems are functioning properly. The technician maintains & performs tasks compliant while working in a fast-paced environment with changing priorities.

Areas of Responsibility

Performs tasks associated with the basic installation, corrective maintenance and daily / weekly / quarterly / annual calibrations of QC analytical laboratory equipment / instruments and microbiology equipment(s).
Coordinates with outside vendors to perform calibrations, certifications, annual PM of laboratory instruments, equipment(s) based on QC instruments schedule list.
Works with QC Instrumentation consultant and outside vendors to learn to identify, locates and diagnoses failure, replaces defective components/parts and performs basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals, and verbal and/or written instructions.
Maintains accurate records keeping for equipment and systems with cGMP compliant. Submit all the executed documents for calibrations, certifications and annual PM performed in-house or by outside vendor(s) in timely manner to QC Documentation.
Uses a variety of hand power and test tools and equipment. Performs routine and non-routine general maintenance tasks as designated by QC management, to include any or all the following areas: analytical & microbiology laboratory equipment; Purified water system; stability chambers.
Coordinates/Plans and implements Calibrations / Certifications on QC systems/equipment with QC Documentation. Maintain update-to-date list of calibrations and annual PM for QC instruments.
Maintains a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
Ensures maintenance work orders are completed on time while adhering to operational standards.
Additional duties as assigned are to work as QC Document transcriber if needed and as documentation record keeper.
Performs monitoring of all EMS alerts and alarms to ensure the environmental systems recording temperature and/or relative humidity are within specified ranges and operating systems are functioning properly.
Downloads recorded data from data loggers and prepares the weekly, monthly, or periodic report for stability chambers and microbiological incubators.

Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned.
Assures GMP compliance according to FDA CFR Part 111 and USPL SOPs / guidelines.
Complies with all regulatory/ in-house requirements (may include but not be limited to safety,

housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the

assigned activity.

Must be able to work extended hours as needed and occasional weekends.
Other duties and responsibilities as assigned by QC in-charge / management.

Other Responsibilities Including Safety:

Works in a safe and responsible manner to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

Associate of Science / BS or related scientific disciplines.
2-5 years’ experience in performing instruments maintenance / calibrations of lab instruments in dietary supplements, food, or OTC / Pharmaceutical manufacturing industry.
Good documentation record keeping and archive skills.

Certifications, Licenses, Credentials:

Skills & Ability

Ability to maintain integrity and honesty at all times and to communicate with transparency.
Ability to work independently or as part of a team.
Self-starter with superior analytical ability and calibrations skills ranging from simple to complex procedures.
Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11
Strong working knowledge of Microsoft Word, Excel.
Good documentation practice and able to write simple, clear reports.
Meets commitments on time and practices time-management skills.
Seeks to identify continuous improvement needs.

Physical Requirements (lifting, etc.):

Ability to navigate office, lab, and/or plant floor working environments.
Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.
Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
On occasion may need to lift up to 20lbs.

Work Environment (Office, Warehouse, temperature extremes, etc.):

Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
May execute up to 40% of their work at the bench level either standing or sitting on a stool.
Work performed in a standard office environment is without unpleasant or hazardous conditions.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.