I. JOB SUMMARY

The QA Operations Supervisor is responsible for the daily coordination and execution of QA shop floor activities, ensuring batch release timelines are met, and setting daily priorities for QA shop floor team members. This position is a hands-on leadership role at Emergent which spends a large amount of time on the production floor directly overseeing operations.

In addition to coordination of shop floor activities, the team lead is responsible for execution of batch review/release, quality system work, and shop floor quality oversight of production activities.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Product Manufacturing Support

• Resolve manufacturing issues of moderate complexity with minimal oversight.


• Performs inspections of the manufacturing facilities to ensure compliance with internal Emergent procedures and CGMPs.


• Reviews Product Manufacturing records to ensure product specification and process requirements are met in accordance with Emergent standard operating procedures.


• Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity. Troubleshoots documentation issues on the floor in real-time with manufacturing associates.

QA Shop Floor Coordination

• Provide scheduling of daily floor support tasks and oversight of floor operations.


• Act as the primary trainer of new hires in the QA shop floor


• Provide performance review feedback to Management.


• Work with area management to ensure scheduling coverage for PTO, and Call-ins to prevent manufacturing process delays.

Quality Systems and Continuous Improvement:

• Reports quality issues that may impact product delivery to Management and Value Stream


• Directly supports internal and external inspections and audits by directly interacting with auditors as a subject matter expert for QA shop floor operations


• Coordinate/lead cross functional teams in process mapping and other exercises designed to facilitate process and system understanding, and problem solving.


• Identification and implementation of shop floor continuous improvement initiatives of moderate complexity to improve product flow and reduce product review cycle times.


• Supports Deviation investigations inclusive of a detailed root cause analysis and sufficient corrective actions.

*Requires vaccination against various viral products, including the Vaccinia virus

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BA/BS (preferably in an Applied Science) or equivalent work experience


• Five (5) years of experience working in an FDA regulated industry.


• Minimum of three (3) years of experience working in Quality


• Experience with pharmaceutical manufacturing operations and cleanroom behavior


• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills.


• Familiarity with Fill/Finish, Visual Inspection, Labeling/Packaging, SOP revisions, performing Root Cause Analysis, CAPA, and Change Control preferred


• Ability to make sound decisions regarding moderate complexity compliance-related issues with a low level of direct supervision.


• Strong Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) and current industry trends


• Strong leadership skills; high level of personal/departmental accountability and responsibility