Stability Chemist, R&D

2 weeks ago

Irving, Texas, United States Medisca Full time

Job Details

Description

A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people.

The Stability Chemist will manage multiple projects within tight timelines, ensuring the requirements of each are met with the highest degree of accuracy and efficiency. Additionally, they will work cross functionally with the R&D team on stability projects focused on the stability of finished products within the compounding industry. They will need to work individually and collaboratively, have excellent analytical thinking skills, and be highly organized.

Your key responsibilities

Perform analytical testing using USP stability indicating methods per the customer established protocols precisely each time. In conjunction with the stability lead and lab manager/supervisor, coordinate testing of multiple programs with the lab staff to ensure testing pulls are completed timely without compromising regular sample testing. Maintain accurate and detailed records of stability studies, test results, and experimental procedures. Collaborate with the quality team and the R&D department to plan and test BUD studies. In conjunction with the stability lead, enter results into the Laboratory Information Management System (LIMS), approve results, trend data, and create reports for the Quality Department. In conjunction with the stability lead and Quality Manager, provides regular updates to internal customers and provide consultation on testing capabilities. Follow all laboratory SOP's and guidelines to ensure compliance with all FDA and DEA regulations. Assist the lab with routine testing as time allows. Follow all PPE and safety protocols Perform other duties as assigned Laboratory upkeep: Maintain organized and tidy laboratory areas and workspacesEnsure all instruments used are well maintained and the workspace is kept neat.Clean and store glassware regularlyCalibrate and perform verification checks on routine use equipment, i.e. analytical balances

Skills, knowledge and abilities

Bachelor's degree in Chemistry or related field. Three (3) to five (5) years of laboratory experience performing analytical testing Proven experience in stability testing with a focus on finished goods in the compounding industry. Equipment knowledge: HPLC (essential), GC, IC, pH, titrators, UV-Vis Working knowledge of cGMP/GLP, ICH, USP/NF (essential), EP, FDA regulations Knowledge of Microsoft Office suite (Word, Outlook and Excel) required Excellent communication skills; fluent English (oral & written) required Manage and prioritize multiple projects Excellent time management and organizational skills Able to work under pressure and successfully function in a fast-paced environment Demonstrates corporate values in the performance of the work and interactions with others.

What's in it for you ...

We invest time and resources into making sure Medisca is as good as the people we hire.

Balance Your Life – PTO, vacation policy and paid statutory holidays Invest in your health – Group Benefit plan and health savings account Your Future is Bright – Opportunities to learn and grow within CED Save for your Future – 401k plan retirement Help us grow – Employee Referral Program We like to have fun – company events throughout the year

We invest time and resources into making sure Medisca is as good as the people we hire.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

We are an equal opportunity employer.

#LI-Onsite

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