Job Description

• Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Identify areas of non-conformance and inform management via the drafting of Deviations as needed to be disposed (unilaterally accepted or rejected) by others. Deviations at this level are minor and involve no patient risk
• Performs initial investigative actions on Deviations, applying well-established techniques and procedures
• Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
• Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
• Revise or review standard procedures.  Revise SOPs in support of Division Procedure Compliance or continuous improvement efforts as needed.
• Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems.
• Audit/review documents as needed for completeness, cGMP’s, company procedures and verification of data. Correct any deficiencies found.

Company Description

Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field