Instrumentation Specialist

RXinsider LTD.; West Columbia (SC); On-site; USD 70,000 - 100,000; Full time

Job summary

RXinsider LTD. in South Carolina is seeking a qualified individual to oversee laboratory instrumentation in a chemistry lab and support related duties.

The role emphasizes cGMP compliance, instrument maintenance for HPLC/GC, and collaboration across QA/R&D to meet regulatory standards.

Qualifications

• Experience with cGMP documentation systems and quality programs.
• Strong knowledge of FDA, USP and industry requirements for analytical instrumentation.
• Must have project management skills and provide technical direction for compliance.
• Direct experience maintaining HPLC, GC and common lab instrumentation.

Responsibilities

• Plans, organizes, and manages preventive maintenance of laboratory equipment.
• Creates or modifies SOPs, forms, logbooks to facilitate instrumentation program.
• Ensures supplies for routine/non-routine maintenance are ordered promptly.
• Focuses on cost savings and value delivery, improving instrument maintenance quality.

Skills

cGMP documentation

FDA/USP compliance

Project management

HPLC maintenance

Gas chromatography

IT troubleshooting

Detail oriented

Written/oral communication

Education

Bachelor’s degree or 7 years in Quality Control Chemistry/R&D

Tools

HPLC

GC

LIMS

Job description

Description

Job Purpose:

• Oversees all aspects of the laboratory instrumentation in the chemistry laboratory
• Assists with additional work duties or responsibilities as evident or required.
• Performs other duties as assigned or apparent.
• Relies on experience and judgment to plan and accomplish goals.
• Performs a variety of complicated tasks under general supervision for which creativity is expected and latitude is given.

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Primary Accountabilities

• Plans, organizes, and manages preventative maintenance of laboratory equipment
• Creates or modifies SOP’s, forms, logbooks, etc. as necessary to facilitate the instrumentation program.
• Ensures that supplies are on hand to perform routine instrument maintenance and that supplies for non-routine maintenance or troubleshooting are ordered promptly as needed.
• Focuses on cost savings and value delivery, ensuring that instrument maintenance is of higher quality and lower cost than vendor maintenance contracts.

NOTE: The Primary Accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties.

Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.

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Skills

Job Specifications and Qualifications:

• Experience with cGMP documentation systems and with implementation of quality systems.
• Strong knowledge of FDA, USP, and industry requirements for analytical instrumentation qualification and maintenance
• Must have strong project management skills and be able to provide technical support and direction with compliance to standards in order to meet business initiatives.
• Must possess direct experience with maintaining HPLC, GC, and other common laboratory instrumentation.
• Must possess strong IT skills and a strong understanding of hardware and software troubleshooting of laboratory instrumentation.
• Must be detail oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and b able to handle multiple projects within limited time frames.

Abilities

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve developmental goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information
• The ability to create new products and processes that add value to the Business, by generating new ideas and applying creative and analytical approaches.

Education/Experience

• Minimum Bachelor’s degree or 7 years of experience working in Quality Control Chemistry and/or Research & Development.

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Working Conditions / Physical Requirements

• Position requires standing (40%), sitting (25%), talking, hearing, typing and walking (35%).
• Position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids and other non-specified hazardous materials that are project specific.
• Position requires safety glasses, respiratory and other non-specified protective equipment to be worn as necessary.

Additional Requirements

• Salary range is based on experience.