Document Specialist

Document Specialist at Aequor Document Specialist at Aequor in Woodcliff Lake, New Jersey Posted in 1 day ago.

Type:

full-time

Job Description:

USA

• -

Documentation Specialist I Location:

Pearl River, NY•

Onsite Duration:

Contract till June 2027 with possibility to extend

Shift:

1st, Shift Monday thru Friday; 7:30am thru 4:00pm

Note:

Shift:

1st

Work Schedule:

Monday thru Friday; 7:30am thru 4:00pm Possibility of extension 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 Fully Onsite Local Candidates Only Work Schedule:

Monday thru Friday; 7:30am thru 4:00pm 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.

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