QC Specialist III - DocumentationAre you a detail-oriented professional with a passion for quality, data integrity, and compliance? Join our Quality Control team in Portsmouth, NH as a QC Specialist III - Documentation, where you will play a crucial role in maintaining the accuracy, functionality, and compliance of raw material specifications that power our drug manufacturing operations.
Working ModelThis is an office?first role. Working together in person supports close, real?time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
What you will get:Compensation for this role will be determined by the candidate?s qualifications, skills, experience, and relevant knowledge.
What you will do:Manage and execute updates to QC chemical raw material specifications requested via compliance records, management requests, or change management channels.
Build and maintain specification templates in Laboratory Information Management Systems (LIMS) and Document Management Systems (DMS).
Collaborate closely with Raw Material Scientists, Coordinators, and cross-functional stakeholders to develop accurate, functional testing specifications.
Author and own specification documents, standard operating procedures (SOPs), and work instructions (WIs).
Apply strict Data Integrity (DI) principles across all tasks in alignment with Lonza DI policies and cGMP guidelines.
Provide clear technical writing, proofreading, and effective communication to support project deadlines and regulatory inspection readiness.
What we are looking for:Experience: Minimum 2 years of editing, document control, or technical writing experience within a regulated cGMP environment (biopharmaceutical/life sciences industry preferred).
Technical Skills: Proficiency in Document Management Systems (DMS), LIMS, and change control practices; familiarity with pharmacopeial compendia (USP, EP).
Software Knowledge: Advanced proficiency in Microsoft Office Suite (Word, Excel) for technical document editing and data formatting.
Education: Associate degree in a Science-related field (or an equivalent combination of education and years of relevant experience).
Competencies: Strong technical writing ability, excellent proofreading skills, adaptability to changing priorities, and a collaborative, customer-focused mindset.
About LonzaAt Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work they want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.
As Lonza?s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.
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