Documentation Specialist I
Aequor JD ·www.aequor.com
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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
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
Frequently asked questions
Who is hiring for the Documentation Specialist I role?
Aequor JD is hiring for the Documentation Specialist I position, a Shazamme client. Apply directly on the employer's career site.
Where is the Documentation Specialist I job located?
The Documentation Specialist I role with Aequor JD is based in Pearl River, NY, US.
What does the Documentation Specialist I role pay?
Aequor JD lists the Documentation Specialist I role at USD 30–34 per hour.
Is the Documentation Specialist I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Documentation Specialist I role?
The Documentation Specialist I position is aimed at mid-level candidates.
How do I apply for the Documentation Specialist I role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.