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Actalent Analytical Chemist III in Waltham, Massachusetts

Actalent Scientific Is Hiring!!!

Description:

Overview

Execute routine and non-routine quality control testing activities as assigned by management. Perform method development, validations, and qualification. Take the lead on CAPA’s, change controls, investigations, and deviations. Perform protocol and technical report authoring. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.

Responsibilities

Responsible for QC Analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, etc).

Author protocols and technical reports as required.

Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.

Troubleshoot any issues with instrumentation and coordinate repair as necessary.

Coordinate with supervisor on scheduling of testing clinical and stability samples.

Participate in data review.

Perform method development for quality control of novel products with established APIs

Coordinate external outsourcing of testing.

Perform method transfers from outsourced testing labs.

Participate in method improvements and optimization activities to improve throughput

Lead CAPA, change controls, investigations, and deviations and the timely closure of these items with Quality Assurance.

Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)

Adherence to cGMPs at all times.

Skills:

Chemistry, Hplc, Analytical chemistry, Gmp, KF, Karl Fisher, GC, gas chromatography, UPLC, Chromatography, Gcms, Method validation, validation testing, raw material, quality control, Laboratory

Top Skills Details:

Chemistry,Hplc,Analytical chemistry,Gmp,KF,Karl Fisher,GC,gas chromatography,UPLC,Chromatography,Gcms,Method validation,validation testing,raw material,quality control

Additional Skills & Qualifications:

Qualifications

Bachelor’s degree in Chemistry or related field

5+ years’ work experience

HPLC / UPLC experience required

Method Development and/or Method Validation experience required

Knowledge of CFR 210,211, USP and FDA/ICH guidance preferred

Experience in a GMP environment preferred

Knowledge of safe laboratory practices

Strong verbal and written communication skills

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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