Documentation Specialist I. Job in Pearl River LilyLifestyle Jobs

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 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 elevate 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

#J-18808-Ljbffr