Sterility Assurance, Aseptic Process Monitor 2nd Shift

Sterility Assurance, Aseptic Process Monitor 2nd Shift

Job Category
: 8000-Quality

Requisition Number
: STERI
005934

• Full-Time
• On-site

TX - Sugar Land 1075,
1075 W Park One Dr #100,
Sugar Land, TX 77478, USA

Our Sterility Assurance (SA), Aseptic Process Monitor plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include gown qualification, EM/PM, media fills, SA investigations, and clean room monitor. The person is the dedicated QA person in the clean room during media fills to ensure good aseptic practices and ensures units are collected, documented, and tested appropriately.

The person is responsible for ensuring EM/PM sampling is occurring and incubated. The SA Aseptic Process Monitor also monitors the compounding activities to assess aseptic behavior in the clean room and provide compo under’s feedback if concerns are found. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 6:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

• Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Schedule & Proctor Media Fills;
  Observes technicians in compounding and routine clean room activities
• Reviews Environmental/Personnel monitoring data to identify any potential trends
• Providing qualification support for personnel on appropriate gowning techniques, aseptic techniques including execution of Compo under and MQA EM Specialist Competency Assessments as well as qualification support for clean room cleaning.
• Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
• Performs EM/PM sampling as needed;
  Maintains EM/PM records
• Maintains Media Fill and Gown Qualification/Requalification records
• Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations
• Assists in the generation of Sterility Assurance reports and documents
• Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
• Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
• Supports department supervision in oversight and prioritization of day-to-day responsibilities.
• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
• Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Evaluation of batches / product for compliance with defined specifications

• Are accurate and well organized, with strong attention to detail
• Express energy, show accountability, can multi-task and work in a fast-paced, quality-rich environment
• Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels
• Have good interpersonal skills and work effectively and efficiently in a team environment to accomplish goals
• Have strong verbal and written communications skills

• A High School diploma or equivalent
• Able to successfully complete a drug and background check
• At least 2 years’ experience in Quality Assurance, Microbiology, Sterile Compounding in pharmaceutical manufacturing
• Previous training and experience in environmental monitoring, and sampling
• Thorough understanding of 21
  
  CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance…