QA Specialist II - Audit Readiness

This is an onsite position.

Job Title: QA Specialist- Audit Readiness (or Senior QA Associate)
Supports activities and initiatives of the quality organization to implement and manage audit readiness activities. This role will manage audit readiness improvement actions with site owners and track to closure. These improvements will be related to the manufacture of biological bulk drug substances, the Quality Control laboratories, facilities and utilities as applicable.

Additional Responsibilities:
In addition to monitoring and tracking open action items, work closely with subject matter experts to understand risk level, timeline, manpower needed to complete action items.
Provide support to the QA Compliance to help prepare for audits, support up-coming audits, update documentation as needed to enhance continuous improvement, etc.
Monitor action item list to add new action items, classify actions into the appropriate focus area and remove action items no longer deemed necessary.
Analyze data from multiple sources to identify common trends and identify areas for improvement.
Support QA Compliance activities as needed (Risk Management, Quality Plans, Internal Auditing, etc.)

Qualifications:

• Bachelor degree in Science.
• 3-5 years of GMP experience, preferably in biologics, audit experience beneficial.
• Effective verbal and written communication skills

What are the top 3-5 skills, experience or education required for this position:
1. Organized
2. Good Verbal/Written Skills
3. Lead Meetings
4. Monitor and track actions to closure