Quality Control / Documentation Analyst

Creative Solutions Services, LLC; Lexington (MA); On-site; USD 52,000 - 76,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Laboratory Assistant to support the QC Raw Materials department in Lexington, MA. You will help author and revise protocols, test methods, and SOPs while assisting with routine laboratory activities as GMP materials are tested and released.

The role emphasizes executing experiments, contributing to documentation, and collaborating with biochem team to ensure compliance with quality systems.

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.

Skills

Lab skills

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.