Analyst III, QA Document Control

Bora Pharmaceuticals • Camden, NJ

11d • $75,789 - $113,684

About The Position

The role of the Analyst III, QA Document Control requires advanced knowledge and understanding of electronic document management systems (EDMS). This individual must be knowledgeable with GDocP and cGMPs regulations. This position serves as a subject matter expert (SME) for the site in regards to EDMS.

Requirements

• Degree in a scientific discipline or equivalent level of skill and experience.
• 3-5 years’ experience with cGMP, FDA regulated industry, and/or electronic document management systems.
• Demonstrated success in independent judgment, technical proficiency, collaboration with others in a cGMP environment.
• Strong skills with Microsoft Office suite
• Excellent attention to detail
• Ability to effectively communicate (oral and written) with internal customers at all levels of the organization.
• Ability to work individually and as part of a team with minimal supervision.
• Ability to work on multiple assignments simultaneously and prioritize tasks to meet deadlines.

Responsibilities

• Excellent working knowledge of the electronic document management systems (EDMS) program (Veeva).
• Act as a trainer on EDMS and other GDocP functions (i.e., serialization, DCC workflows, etc.).
• Issue documents (batch records, logbooks, lab notebooks, etc.) in a timely manner to support site operations.
• Provide support during regulatory and internal inspections.
• Respond to internal and external audit findings.
• Prepare and present reports and metrics to leadership around documents (DCCs, periodic reviews, document reconciliation, etc.)
• Revise Quality Assurance SOPs and Work Instructions as required to ensure procedures are compliant with cGMP.
• Maintain records archives both on-site and at off-site archive facility.
• Support cross functional teams/departments in troubleshooting technical issues related to Document Control.
• Additional Quality Assurance activities / support activities as required (Training of peers for document control, QA Release, etc.).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level