Quality Control Documentation Specialist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Quality Control Documentation Specialist

Location: Portsmouth, NH, 03801

Duration: 8 Months

Job Type: Temporary Assignment

Work Type: Onsite

Summary

The Documentation Specialist is responsible for maintaining QC chemical raw material specifications through the Document Management System (DMS) and Laboratory Information Management System (LIMS). The role supports specification accuracy and functionality for site production while working with Raw Material Scientists, Coordinators, and cross-functional stakeholders. The position requires knowledge of compendia (USP, EP, etc.), computerized management systems, Microsoft Suite, data integrity principles, and cGMP awareness.

Responsibilities

• Manage updates to raw material specifications requested through compliance records, management requests, or other points of entry.
• Collaborate with Raw Material Scientists and Coordinators to provide useful testing specifications.
• Communicate clearly with cross-functional stakeholders and raw materials team members regarding specification changes.
• Own specification documents and relevant SOPs and Work Instructions (WIs), as applicable.
• Apply Data Integrity principles in accordance with Lonza DI policies, guidelines, and procedures.
• Create and update LIMS templates for new and existing raw material specifications.
• Perform other duties as assigned.

Required Skills & Qualifications

• Associate's degree in Science preferred/required; a combination of education and years of experience will be considered.
• 0 4 years of experience; minimum 2 years of editing and/or regulated industry experience.
• Advanced proficiency in Microsoft Office Suite, particularly Word and Excel.
• Excellent proofreading and editing skills.
• Experience with Document Management Systems (DMS) and document control practices.
• Experience with document change management.
• Experience in technical writing, including protocols, reports, specifications, and methods.
• Knowledge of LIMS and computerized management systems.
• Knowledge of compendia, including USP and EP.
• Awareness of cGMP requirements.
• Understanding and application of Data Integrity principles.
• Ability to effectively interpret written and verbal instructions.
• Strong communication and collaboration skills.

TekWissen Group is an equal opportunity employer supporting workforce diversity.