Sterility Assurance Intern

Quva Pharma • Sugar Land, TX

294d

About The Position

The Sterility Assurance (SA) Intern is a direct labor role that will be exposed to gown qualification, EM/PM, media fills, SA investigations, and clean room monitoring. The person is dedicated to ensuring good aseptic practices and ensures units are collected, documented, and tested appropriately. The SA Intern also assists in monitoring the compounding activities to assess aseptic behavior in the clean room and provide feedback if concerns are found. This is a role working Monday through Friday from 8:00 AM to 4:00 PM 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.

Requirements

• Legally authorized to work in the job posting country
• High school diploma or GED from recognized institution or organization required
• Must be actively pursuing a bachelor's degree from an accredited institution, with an anticipated graduation date within the next two years
• Must be in good standing with accredited institution where pursuing degree
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product
• Microsoft Word and Excel skills

Nice To Haves

• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
• Demonstrated core values, professionalism, maturity through various campus or community sports, volunteer activities, or previous work history
• Works closely with the department supervisor to ensure alignment on day-to-day priorities
• Detail-oriented with strong verbal and written communications skills
• Supports the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards

Responsibilities

• Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Schedule & Shadow Media Fills
• Observes technicians in compounding and routine clean room activities
• Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
• Maintains EM/PM records
• Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
• Assists in Sterility Assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) and provides feedback
• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP

Benefits

• Set, full-time, consistent work schedule
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Industry: Management of Companies and Enterprises
• Education Level: High school or GED