Onsite

Pay rate - -

The QC Stability / Lab Technician Associate is responsible for assisting with the company's stability program for commercial and post-approval change batches monitored on the stability program and to support the QC Laboratories with sample receipt / control and glassware maintenance.

For the stability department, this includes the performance of area responsibilities necessary to ensure that stability activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with Sandoz objectives.

This is not an exhaustive, comprehensive listing of job functions. Stability Management, as required, may assign other activities in addition to the following.

Receive and store all stability samples in temperature controlled environment(s) in accordance with SOP and protocol requirements.

Coordinate sample pulls from protocol requirements, pull samples and submits to Quality Control Laboratory. Prepare sample labels and aliquot stability samples.

Maintain the stability room in an organized manner and in compliance with cGMPs. Set up stability studies and enter results into the stability system.

Maintain stability files in an organized manner for review. Adhere to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and USP / NF etc.

Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Plant, and Corporate quality and Safety goals.

Conducts self in a manner consistent with Sandoz Values and supports Quality Culture initiatives. For the QC Laboratories, assist with Lab Technician responsibilities.

Maintain established inventory list of chemicals and other laboratory items. Receives newly purchased items and distributes to analysts.

Restock as required. Collection of used glassware from designated laboratory locations, cleaning of glassware using a dishwasher or by hand when necessary, restocking of clean glassware in specified areas.

Checks receipt of laboratory samples for accuracy, documents receipt of samples in appropriate logbook and returns sample submission sheets to initiating department, manual entry into logbook and LIMS entry.

The employee is frequently required to sit while performing the duties of the job. The employee is occasionally required to stand, walk, and reach with hands and arms as well as being able to lift up to 50 pounds The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Note : This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility.

If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Pharmaceutical manufacturing and / or Quality Assurance monitoring experience highly preferred Knowledge of cGMPs and the ability to follow SOPs.

Associate's Degree or equivalent experience in lieu of a degree.

Perform other duties as required.

Good English written and oral communications skills required

Strong organizational skills / attention to detail required

Basic mathematical skills required

Working knowledge of Microsoft Word, Excel; Proficiency with computer applications

Ability to multi task and adapt to changing priorities

Last updated : 2024-05-09