Documentation SpecialistKatalyst HealthCares & Life Sciences • Ridgefield,, NJ

Documentation Specialist

Katalyst HealthCares & Life Sciences • Ridgefield,, NJ

[job_card.30_days_ago]

[job_preview.job_type]

[job_card.full_time]

[job_card.job_description]

Roles & Responsibilities :

Documentation Management.
Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO guidelines.
Review production schedules with various departments to ensure alignment and efficiency.
Manage the lifecycle of production documents, including creation, review, approval, and archiving.
Manage the printing, distribution, and tracking of all production-related documentation.
Batch Production Records (BPRs), Bills of Materials (BOMs), Protocols, and Labels for production, ensuring accuracy, traceability and compliance.
Utilize systems such as SAP and other relevant software for documentation and data management.
Cross-functional Collaboration on documentation improvement projects to maintain integrity and compliance.
Liaise with various teams including Quality, Regulatory Affairs, and Supply Chain to ensure seamless information flow.

Education & Experience:

High school diploma or equivalent experience required.
- years in a GMP manufacturing environment
Experience in the pharmaceutical or medical device industry
Knowledge, Skills, Abilities
Strong knowledge of cGMP regulations and ISO standards
Proficiency in Microsoft Office suite
Excellent organizational and communication skills
High school diploma or equivalent experience required.
- years in a GMP manufacturing environment.
Experience in the pharmaceutical or medical device industry.
Strong knowledge of cGMP regulations and ISO standards.
Proficiency in Microsoft Office suite.

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