1532 QC Systems Specialist
$120,640–$133,058 year
On-sitePortsmouth, New Hampshire, United States
Job Summary
Manage updates to raw material specifications and create LIMS templates for new and existing documents. Collaborate with Raw Material Scientists to develop compliant testing specifications while owning specification documents, SOPs, and work instructions. Perform proofreading, editing, and technical writing for protocols and reports, applying Data Integrity principles throughout. Support document change management processes, including review, routing, and approvals in the Document Management System. Ensure highest standards of quality in documentation and support cGMP compliance by notifying management promptly of regulatory inspections or process deviations. This role requires knowledge of compendia, computerized management systems, and Microsoft Office to streamline documentation processes within the QC organization.
Required Qualifications
- Associate's degree in a Science field
- 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
- Adherence to cGMPs
- Knowledge of compendia (USP, EP)
- Knowledge of computerized management systems
- cGMP awareness
- Knowledge of Document Management System (DMS)
- Knowledge of Laboratory Information Management System (LIMS)
Desired Qualifications
- Relevant certifications in document control, quality systems, or compendia familiarity
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