Title: Documentation Specialist I
Location: Pearl River, NY
Duration: 6 Months Possible Extension
Pay Range: $30-$35/hr
Shift- 1st
Work Schedule – Monday thru Friday; 7:30am thru 4:00pm
Manager Notes:
- 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
Preferred skills:
- Manufacturing GDP experience Deviations
Description:
- 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. 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