QC LIMS & Documentation Specialist (Pharma / cGMP)

Advance your career with a premier global biopharmaceuticals leader in historic Portsmouth, NH. This is a 100% onsite, first-shift contract role.

About the role

Manage QC chemical raw material specifications and data entry within LIMS and Document Management Systems (DMS) to support high-impact manufacturing operations.

Responsibilities

• Manage, update, and own chemical raw material specifications, SOPs, and work instructions via compliance records or change requests.
• Create and update LIMS templates and master data for new and existing raw material specifications.
• Collaborate cross-functionally with Raw Material Scientists and Coordinators to ensure accurate, functional testing specifications.
• Apply strict Data Integrity principles across all documentation, change management, and LIMS entries in compliance with cGMP standards.
• Communicate effectively with stakeholders to ensure specification updates are accurately executed.

Requirements

• Associate degree in a science-related field.
• Minimum of 2 years of editing, document control, or regulated biotech/pharma industry experience.
• Demonstrated experience using Document Management Systems (DMS) and managing document change processes.
• Strong technical writing skills and advanced proficiency in MS Office (Word and Excel).
• Working knowledge of cGMP regulations and compendia standards (e.g., USP, EP).

Preferred Qualifications

• Direct experience creating and managing templates within a LIMS platform.

Skills

• MS-Excel
• Laboratory Information Management Systems (LIMS)
• Good Documentation Practices (GDP)

Pay

$50.00 - $53.96 per hour

Schedule

First shift, 9 AM to 5 PM

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan

All benefits are based on eligibility.