QC Systems Specialist

Responsible for creating, maintaining, and ensuring accuracy of QC chemical raw material specifications and related documentation used to support site production. This role works primarily within the Document Management System (DMS) and Laboratory Information Management System (LIMS), and requires knowledge of compendia (USP, EP), computerized management systems, Microsoft Office, and cGMP awareness to support the raw materials team and broader QC organization.

Responsibilities

• Manage updates to raw material specifications requested via compliance records, management requests, or other points of entry.
• Create and update LIMS templates for new and existing raw material specifications.
• Collaborate closely with Raw Material Scientists and Coordinators to develop practical and compliant testing specifications.
• Own or maintain specification documents, relevant SOPs, and work instructions as assigned.
• Provide clear communication to cross-functional stakeholders (Quality Control Management, Quality Assurance — Raw Materials, Part Number Team) to ensure specification changes are accurately and effectively implemented.
• Apply Data Integrity principles in all aspects of work in compliance with DI policies, guidelines, and procedures.
• Support document change management processes, including review, routing, and approvals in the DMS.
• Perform proofreading, editing, and technical writing for specifications, protocols, and reports.
• Participate in continuous improvement activities to streamline documentation processes.
• Perform other duties as assigned.

Requirements

• Associate’s degree in a Science field (or a combination of education and relevant experience).
• Minimum 2 years editing and/or regulated industry experience (entry level: 0–4 years).
• Advanced MS Office skills, particularly Word and Excel.
• Excellent proofreading and editing skills.
• Experience with Document Management Systems and document control practices.
• Experience with document change management and routing.
• Technical writing experience for specifications, protocols, and reports.
• Ability to interpret written and verbal instructions coherently and effectively.
• Strong attention to detail, organization, and time management.
• Ability to work in a fast-paced environment with tight deadlines.

Competencies & Behaviors

• Agility: Able to learn quickly, adapt to changing directions, and work with different internal/external customers.
• Business Acumen: Understands priorities and acts to support business units; proposes ideas to improve and streamline activities.
• Collaboration: Works with internal customers to achieve results, listens respectfully to others’ ideas, and shares information.
• Customer Focus: Seeks to understand customer needs through meetings and delivers high-quality results; works with technical transfer teams to drive results.
• Driving Results: Follows up on projects to meet deadlines, ensures quality of work, and demonstrates strong technical writing capability.
• Leadership: Drives assignments to completion and takes ownership of deliverables.
• Quality: Ensures the highest standard of quality in documentation and supports cGMP compliance. Notifies management promptly of regulatory inspections, serious GMP deficiencies, process deviations, or product defects.
• Safety: Participates in safety initiatives and reports safety incidents. Complies with site safety policies.

Pay

The hiring rate for this position is $58 to $63.97 per hour. The base pay offered will take into account internal equity and may vary depending on candidate's geographic region, job-related knowledge, skills, and experience.