Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.

Job Title

• Senior Scientist / Auditor

Position Description

• Audit of Product Development documents supporting FDA and other Regulatory submissions, responsible for retrieving/copying documents to support regulatory authority inspections. This position will communicate the status of any emerging issues relating to data audit on a monthly basis.
  
  

Position Responsibilities

• Audits all documents supporting regulatory filings.
• Assists in retrieving documents for Regulatory inspections.
• Assists management in training of new auditors.
• Revises SOPs applicable to the job as needed.
• Provides weekly updates of the status of OOS/OOT/Deviations/Audits 
• Conducts Quarterly Management meetings and maintains monthly metrics
• Responsible for establishing Quality Technical Agreements with PD contract Labs
• Responsible for archive activities as needed.
• Provides QA oversight for Clinical Supplies labeling activities.  

Position Requirements

• BS degree in basic sciences (Chemistry preferred). 
• Minimum 4-7 years or 8-10 years (for Senior level position) in laboratory or auditing experience in the pharmaceutical industry.
• Excellent communication and teamwork skills are essential.
• Must have the ability to comprehend scientific data generated by the Product Development team.
• Must be proficient in using computer applications such as Microsoft Word and Excel.