Documentation Specialist I

Immediate need for a talented Documentation Specialist I. This is a 06+ months contract opportunity with long-term potential and is located in Pearl River, NY (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-15911

Pay Range: $30 - $33/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities :

• 1st Shift: 1st Shift: 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.

Key Requirements and Technology Experience:

• Must have skills: - Fully onsite, Free parking. Possibility of extension High School diploma 5 years Degree, 3 + years of experience bachelor's degree, final batch review 1+ year of experience
• 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
• Manufacturing GDP experience
• Deviations
• 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.
• Years of Experience: 0 - 3 Years

Our client is a leading B iopharmaceutical Industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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