Quality Control / Documentation Analyst

Katalyst CRO; Lexington (MA); On-site; USD 42,000 - 64,000; Full time

Job summary

Katalyst CRO is seeking a detail-oriented laboratory professional to support the QC Raw Materials department at our Lexington, MA site. The role focuses on performing experiments per SOPs, assisting in instrument/method projects, and contributing to documentation to ensure GMP compliance.

The successful candidate will have a minimum of a bachelor's degree in chemistry/biology/biochemistry and some lab experience; proficiency with MATLAB or similar chemometric software is a plus.

Qualifications

• Essential: Minimum Bachelor's degree in Chemistry/Biology/Biochemistry.
• Desired: Experience in a laboratory environment is preferred.
• Experience with Matlab or other chemometric software.

Responsibilities

• 75% Executing experiments and procedures as detailed by lab manager and staff.
• 25% Writing / revising documents procedures and validation documentation.

Education

Bachelor's degree in Chemistry/Biology/Biochemistry

Tools

MATLAB

Job description

Job Description

• Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team.


• This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.


• In this role, the primary responsibility for the individual in this position is to assist in instrument/method projects with some supervision. The projects may require attending meetings based on the specific project, document writing/revising to ensure compliance with regulations and quality control practices.


• The person in this role may also be asked to revise documents to assist in the daily operations of the team.

Responsibilities

• 75% Executing experiments and procedures as detailed by lab manager and staff.


• 25% Writing /revising documents procedures and validation documentation.

Education And Experience Requirements

• Essential: Minimum Bachelor's degree in Chemistry/Biology/Biochemistry.


• Desired: Experience in a laboratory environment is preferred.


• Experience with Matlab or other chemometric software.