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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

Documentation Area Specialist II - Contract - Clayton, NC

Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward!

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is seeking a Documentation Specialist to support the creation, revision, and management of site documentation, including Standard Operating Procedures (SOPs) and system specifications..

Primary Responsibilities:

This role involves ensuring clarity, compliance, and standardization in documentation processes while collaborating with cross-functional teams.

Skills & Requirements:

Experience in documentation, technical writing, or document processing, preferably in engineering, life sciences, or related industries.
Familiarity with GMP concepts, particularly GMP documentation, is preferred.
Knowledge of construction-engineering turnover packages is a plus.
Understanding of process improvement methodologies such as LEAN is advantageous.
Strong communication and organizational skills.
Proficiency in tools such as Procore, Smartsheet, MS Word, Adobe Acrobat Pro, Excel, PowerPoint, and Visio.
Proven ability to plan, organize, and manage complex projects involving cross-functional teams.
Change management experience is a plus.

The Documentation Area Specialist's responsibilities will be:

Create, review, and revise site documentation, including SOPs and system specifications.
Ensure documents are clear, reader-friendly, and compliant with relevant standards.
Manage document workflows using site document management tools.
Support and contribute to standardization and process improvement projects.
Collaborate with internal and external stakeholders to maintain effective relationships.
Assist in meeting project metrics and timelines.
Engage in systematic problem-solving to enhance document processes and quality compliance.
Adhere to safety and environmental requirements.
Perform other duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is acting as an Employment Agency in relation to this vacancy.

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