3rd Shift QA, Associate Specialist

Role Summary

3rd Shift QA, Associate Specialist is a quality-focused role within a pharmaceutical manufacturing environment. The position supports environmental and utility monitoring, data trending, investigation and CAPA activities, and review of batch documentation under the direction of the Director, Wilson Quality Operations. The role requires an associate degree or equivalent experience and GMP/pharmaceutical industry experience.

Responsibilities

• Qualification, routine and per process monitoring of the facilities, utilities and personnel
• Trending for Utility Systems and Classified Areas including evaluating data for adverse trends
• Collection and submission of samples in GLIMS
• Authoring of investigations and implementation of appropriate corrective/preventative actions
• Assist with protocol development and execution of the Process Simulation program
• Adherence to departmental Quality metrics
• Provide Shopfloor support and review of batch generated documentation
• Performs other duties as assigned
• Directly support performance qualification activities
• Collection of utility systems samples including water, clean steam, and clean dry air
• Execute environmental sampling of classified areas including active viable air, non-viable air, and surface sampling
• Compile and author annual reviews
• Provide data entry, review, and approval as required in GLIMS
• Provide summaries of test results to appropriate personnel as necessary
• Compile and evaluate environmental monitoring data for adverse trends
• Conduct investigations for deviations and Out of Specification results; interpret our company's Quality policies, GMPs and other agency regulations for application to Wilson Operations
• Identifies and implements continuous improvement activities
• Batch documentation review and/or approval
• Provide shopfloor support, through aseptic observations or other observations, during operations
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
• Schedule: 11:00 pm to 7:00 am Mon-Fri

Qualifications

• Required: Must possess a minimum of one (1) year of GMP pharmaceutical industry experience.
• Required: Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
• Required: Ability to perform routine assignments and develop competence by performing structured work assignments.
• Required: Ability to use existing procedures to solve routine and standard problems.
• Required: Promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.
• Required: Readily accepts performance feedback and incorporates this feedback into future performance.
• Required: Ability to interpret our company's Quality Policies, Procedures and Guidelines for daily application.
• Required: Ability to independently respond to basic requests for data and trending of data.
• Required: Willing to work irregular hours to support multi-shift operation on an as needed basis
• Preferred: GLIMS experience preferred
• Preferred: Experience with aseptic filling, environmental monitoring and process simulations.
• Preferred: Ability to learn new processes and computerized systems with limited support.
• Preferred: Experience in continuous improvement, LEAN manufacturing, problem solving, and/or Right First Time methodologies.
• Preferred: Strong written and verbal communication skills including technical writing experience with investigations, change requests, standard operating procedures, protocols, etc.

Skills

• Aseptic Filling, cGMP Compliance, Deviation Management, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Technical Writing, Test and Evaluation (T&E)

Education

• Must possess at a minimum an associate degree or equivalent experience in the pharmaceutical industry