Job Title: Documentation Associate

Work Location: Middlesex County, New Jersey

Summary:

Seeking a Documentation Associate for a 1-year contract position. This role involves supporting documentation and data entry tasks within an operations team, with a transition to assisting with documentation for a new SAP HANA implementation. The position requires strong attention to detail, proficiency in Microsoft Office, and the ability to manage multiple assignments.

Responsibilities:

• Perform data entry and documentation tasks using Microsoft Word and Excel with high accuracy.
• Prepare and revise manufacturing and packaging batch records, as well as standard operating procedures, following current guidelines.
• Scan, save, and organize executed batch records into a documentation database.
• Review master batch production records to ensure compliance and accuracy.
• Assist in the preparation of protocols and reports as required by operational needs.
• Support the transition and documentation efforts related to the implementation of SAP HANA.
• Edit, update, and maintain various documents, ensuring all records are current and compliant.
• Perform additional duties related to document preparation and management as assigned.

Qualifications:

• High school diploma or GED required; degree preferred.
• Minimum of 1-2 years of experience in pharmaceutical, drug, cosmetic, FDA-regulated, or medical device industry preferred.
• Experience with SAP transactions preferred.
• Strong Microsoft Office skills, especially Excel and Word.
• Knowledge of GxP and current good manufacturing practices (cGMP) preferred.
• Excellent verbal, written, and interpersonal communication skills.
• Experience working in an international, multicultural, matrix organization is a plus.
• Strong organizational and time management skills, with the ability to prioritize and manage multiple assignments independently or collaboratively.
• Self-starter with a hands-on approach and a positive, can-do attitude.

Published Category: Quality & Validation