Analyst II, Quality Assurance
About The Position
Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.JOB SUMMARY The Analyst II, Quality Assurance position is a quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories. Responsible for QA oversight of production process, and the execution of routine Quality System work on the manufacturing floor. The Analyst II also serves as a subject matter expert in Emergent QA routine operations and may represent Emergent during on-site inspections. This position frequently interacts with team leads, supervisors, and other cross functional peers.
Requirements
- BA/BS (in an applied science preferred) or equivalent work experience.
- 2-5 years of experience working in a regulated industry.
- Experience with quality assurance preferred.
- Experience with aseptic processes preferred, BSL-2 and BSL-3 preferred.
- Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills.
- Ability to make sound decisions regarding moderately complex compliance-related issues with supervision support.
- Must exhibit Personal/departmental accountability.
- General Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP).
Responsibilities
- Provide direct quality “on the floor” support and oversight, troubleshoots basic issues with supervisor support.
- Follows written instructions in the routine review of laboratory and production records in accordance with Emergent standard operating procedures and good documentation practices (GDP) and principles of data integrity.
- Perform label control processes such as counting, verification, issuance, receipt and reconciliation of components.
- Coordinates with other Quality Assurance team members to ensure adequate support of manufacturing operations.
- Assist with Procedure Reviews and Product Dispositions, Release intermediate and raw materials for further processing.
- Reviews routine work orders, return to service, and other documentation to ensure that equipment and utilities are fit for use.
- Act as a support/backup Quality Assurance subject matter expert for an integrated process team.
- Provide input to authors and task owners for document revisions, deviation investigations, CAPAs, and change controls related to Document Control processes
- Supports minor and mid-level deviation investigations, which may contain root cause analysis and corrective actions.
- Ensure documents meet established formatting standards
- Manage implementation activities of documents, including lifecycle states in the Document Management System, user notifications, and issuance & reconciliation of controlled copies
- Complete record activities including issuing, reconciling, scanning, and archiving
- Troubleshoot and provide support for internal customers with technical questions related to Document Control processes and IT applications
- Participate in routine audits of Document Control processes and provide recommendations for improvement
- Identify opportunities for improvement within scope of work
- Participating in department organization and 6S activities
- Provide campus support during internal audits and regulatory inspections of Emergent quality systems, serve as a subject matter expert to support regulatory interviews on routine quality assurance tasks.
- Participate on response teams to address observations and recommendations made during internal audits and inspections
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
