Associate QC Scientist

Artech Information System LLC; Harvard (MA); Sur place; USD 80 000 - 120 000; Plein temps

Résumé du poste

A leading information technology consulting firm is hiring for a role focused on supporting raw material qualifications and method transfers. The ideal candidate will have a Bachelor's degree in chemistry or a related field and six years of relevant experience, or four years with a Master’s degree. Responsibilities include documenting data under cGMP and reviewing standard operating procedures. Interested candidates should contact Praveen.arora at artechinfo.com.

Qualifications

• Bachelor's degree in a related scientific discipline is required.
• Master's degree is preferred.
• 6 years experience with Bachelor's or 4 years with a Master's.

Responsabilités

• Support raw material qualifications and method transfers.
• Document analytical data under cGMP and corporate guidelines.
• Write/review SOPs and validation protocols.
• Document analytical data under cGMP and corporate guidelines.
• Participate and resolve laboratory investigations of unexpected analytical results.
• Write/review SOPs, test methods, material specifications, validation protocols and reports.
• Support cGMP laboratory initiatives following laboratory SOPs.
• Other duties may be assigned.

Connaissances

Data analysis

Method development

cGMP compliance

SOP writing

TOC testing

Data analysis

cGMP documentation

SOP writing

Formation

Bachelor’s degree in chemistry, biochemistry or related scientific discipline

Master’s degree preferred

Outils

HPLC

UV-VIS

SDS-PAGE

GC

Description du poste

• Support raw material qualifications, method transfers, and validation of assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis and various HPLC methodologies (e.g. peptide map and carbohydrate analysis).
• Review compendial methods (USP, EP, JP) for alignment with internal raw material test procedures and specifications.
• Perform routine/non-routine data analysis calculations.
• Document analytical data under cGMP and corporate guidelines.
• Participate and resolve laboratory investigations of unexpected analytical results.
• Write/review SOPs, test methods, material specifications, validation protocols and reports.
• Support cGMP laboratory initiatives following laboratory SOPs.
• Other duties may be assigned.

Qualifications

Bachelor’s degree in chemistry, biochemistry, or related scientific discipline required.

Master’s degree preferred.

6 years experience with a Bachelors or 4 years with a Masters.

Additional Information

Interested candidates may contact at Praveen.arora at artechinfo.com or 973-507-7593.