GMP Documentation - QC

Job Description

Job Description

QC Specialist III – Documentation

Location: Portsmouth, New Hampshire

Position Summary

We are seeking a detail-oriented QC Specialist III – Documentation to support Quality Control documentation and chemical raw-material specifications within a regulated pharmaceutical or biotechnology manufacturing environment.

This position is responsible for creating, maintaining, and updating raw-material specifications using a Document Management System (DMS) and Management System Laboratory Information Management System (LIMS) . The successful candidate will work closely with QC Raw Material Scientists, Coordinators, Quality Assurance, and other cross-functional stakeholders to ensure specifications are accurate, functional, compliant, and suitable for supporting site manufacturing operations.

Key Responsibilities

• Manage updates to raw-material specifications initiated through compliance records, management requests, change requests, or other approved channels.
• Create and revise QC chemical raw-material specifications.
• Create and update LIMS templates for new and existing raw materials.
• Collaborate with Raw Material Scientists and Coordinators to develop clear and effective testing specifications.
• Communicate specification changes and compliance-record requirements to cross-functional stakeholders.
• Ensure approved changes are accurately and effectively implemented.
• Own or maintain specification documents, SOPs, work instructions, and other controlled documents.
• Review and edit technical documents for accuracy, consistency, clarity, and compliance.
• Apply data-integrity principles in accordance with applicable policies, procedures, and regulatory expectations.
• Support document change-control and document-management activities.
• Track assigned projects and documentation updates to ensure deadlines are met.
• Identify opportunities to improve and streamline documentation processes.
• Follow applicable cGMP, quality, environmental, health, and safety requirements.
• Promptly escalate significant GMP deficiencies, process deviations, product-quality concerns, and documentation issues.
• Perform other duties as assigned.

Required Qualifications

• Associate degree in science or a related field.
• A combination of relevant education and professional experience may be considered.
• Minimum of two years of document editing, document control, or regulated-industry experience .
• Experience working in a pharmaceutical, biotechnology, medical-device, or other regulated environment.
• Knowledge of current Good Manufacturing Practices ( cGMP ).
• Experience using document management systems and following document-control practices.
• Experience with document change management.
• Strong technical writing experience involving specifications, methods, protocols, or reports.
• Advanced proficiency with Microsoft Office, particularly Word and Excel .
• Excellent proofreading, editing, and attention-to-detail skills.
• Ability to accurately interpret written and verbal instructions.
• Business-fluent English communication skills.

Preferred Qualifications

• Experience working with LIMS and creating or maintaining LIMS templates.
• Knowledge of compendial requirements, including USP and EP .
• Experience supporting QC raw-material testing or specification management.
• Familiarity with data-integrity requirements in a cGMP laboratory or manufacturing environment.
• Experience collaborating with Quality Control, Quality Assurance, Technical Transfer, and cross-functional teams.

Key Competencies

• Strong organization and document-management skills.
• Ability to manage competing priorities and meet tight deadlines.
• Clear written and verbal communication.
• Ability to adapt to changing priorities and customer requirements.
• Strong collaboration and internal customer-service skills.
• Commitment to accuracy, quality, and regulatory compliance.
• Ability to independently drive assignments through completion.

Physical and Work Requirements

• Ability to work in a busy environment with tight deadlines and fluctuating workloads.
• Regular sitting and occasional standing, walking, reaching, bending, kneeling, squatting, stair climbing, ladder climbing, driving, and gowning.
• Ability to occasionally lift up to 50 pounds .
• Must complete required health and safety training and comply with all site safety procedures.