Documentation Specialist I

Job Description

Duties and Responsibilities:

• Track and review manufacturing batch records to ensure compliance with regulatory requirements.
• Follows up with Manufacturing Technicians to ensure corrections are completed in a timely manner.
• Maintain error tracking metrics to address and correct repeated violations of GDP.
• Coach shopfloor technicians on GDP as applicable.
• Identify and escalate GDP issues that could affect the safety, efficacy and quality of drug substance.
• Review batch record structure and recommend simplifications to minimize errors – as applicable.
• Ensure batch record review cycle time.
• Participate in deviation investigations and CAPA creation – as applicable.

Education and Experience:

• High School diploma 5 years AA Degree, 3 + years of experience Bachelor’s degree, final batch review 1+ year of experience.

Must Have:

• Experience; CAPA, Batch review, technical writing, knowing how use documentation systems, locate errors and change action requirements.
• Quality system, Tech writers, CAPA, ERP, experience.
• Documenting systems or similar for tech writer.
• Pharma/ bio tech is required.
• Must be detail oriented and able to work quickly with a high degree of accuracy.
• Must possess sound interpersonal and information gathering skills, be able to work in a team environment and interact effectively with others.

Preferred skills:

• Manufacturing GDP experience.
• Deviations.