Analyst - Full-time / Part-time

Performs testing for raw materials, packaging components, intermediate products, finished products, and ILQ’s as per current monograph/testing methods, USP, NF, proposed monograph or validation protocols (where applicable).Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.
Evaluates and analyzes data to identify and understand quality performance trends.
Performs laboratory equipment daily calibrations, verifications, qualification, validation and troubleshooting. Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and of all laboratory notebooks and worksheets as per QC SOP’s. Participates in process validation, laboratory equipment qualification, and analytical method transfers. Recommends change to SOP’s, protocols, monographs, etc.
Provides support in the investigations of non-conforming results and resolution of investigations.
Ensures that use approved validated methods and specifications, to perform required testing when is involved in testing of finished products, API’s, biological drug substances, raw materials, intermediates / components and ensures all necessary testing is carried out.
Ensures that stability studies testing follow specific protocols and procedures.
 

Requirements:
- B.S. degree in Science with a major in Chemistry, Biochemistry, Industrial Chemistry, Biology or Medical Technology
- One (1) year of experience in a Pharmaceutical environment
- Working knowledge of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc)
- Knowledge on analytical data collection and documentation or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.)
- Knowledge of laboratory equipment, such as: UV-Visible, FTIR, HPLC, GC, CE, Scanners, micro plate readers
- Ability to perform basic troubleshooting, PM and/or calibration of laboratory equipment (column care and use, tools, in-line filters, etc.)
- Ability to conduct a variety of analytical techniques
- Proficiency in oral and written communication skills in both, English and Spanish
- Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.