JOB SUMMARY
The Analyst III, Quality Assurance position is an experienced quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories.
The Analyst III is responsible for QA oversight of an area of the production process, management and execution of Quality System work associated with that area. The Analyst III also serves as a subject matter expert in Emergent quality systems and may represent Emergent during on-site inspections. This position frequently interacts with department managers, internal customers, and other cross functional peers to gain alignment and make quality related decisions.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Provide quality on the floor support and oversight to help resolve manufacturing issues independently. Performs audits of the manufacturing facilities and laboratories to ensure compliance with internal Emergent procedures and cGMPs.
• Reviews Product Manufacturing and Testing records to ensure product specification and process requirements are consistently met in accordance with Emergent standard operating procedures
• Prepares records of product manufacturing to support product release. Release intermediate materials for further processing.
• Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity.
• Reviews work orders, equipment return to service, and other documentation to ensure that equipment and utilities are fit for use
• Perform labeling and packaging control processes such as counting, verification, issuance, receipt and reconciliation of components, and verifying area clearances
• Supports Major and Critical Non-conformance investigations inclusive of a detailed root cause analysis and sufficient corrective actions
• Serves as a decision-maker on major procedure changes, deviations, corrective and preventive actions, change control and site projects.
• Writes and reviews moderately complex technical documents including validation, testing, and stability data, for completeness accuracy.
• Act as a Quality Assurance subject matter expert for an integrated process team
• Support internal and external inspections as a subject matter expert
• Responds to customer inquiries and complaints.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS (in an applied science preferred) or equivalent work experience.
• 6-8 years of experience working in an FDA regulated industry with at least 3 years of experience in quality assurance
• Experience with aseptic processes, clean room gowning, and Pharmaceutical quality system work preferred
• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
• Ability to make sound decisions regarding moderate to high complexity compliance-related issues.
• High level of personal/departmental accountability and responsibility.
• Strong familiarity with pharmaceutical industry guidance’s (ICH, CFR 21.210-211, USP)
