Quality Assurance Associate

Quality Assurance Associate

Radiomedix, Inc., a contract manufacturing biotechnology company located at 19705 Aldine Westfield Rd., Humble, TX 77338, is seeking a Quality Assurance Associate (Operations) to work in radiopharmaceutical manufacturing. The successful candidate will conduct QA review of all drug products on‑site, focusing on high‑priority projects integral to upcoming clinical trials.

• Supports quality on the floor activities within a cGMP operation in a 21 CFR 211 facility.
• Supports the initiation and assignment of quality events such as deviations, CAPAs, and out-of-specifications (OOS).
• Performs release of quarantined raw materials, identifies and assists in resolving issues related to quarantine/rejection of materials.
• Completes documentation in accordance with GDP.
• Reviews executed records for GMP support areas including facility maintenance, material management, and QC laboratory maintenance.
• Prepares and files all executed documents for archiving per SOP.
• Reviews training records and ensures training documents are filed and up to date.
• Reviews equipment maintenance records and keeps equipment files current.
• Assists in training staff in quality procedures.
• Prepares records for off‑site storage.
• Maintains and updates tracking databases as required.
• Performs real‑time review of manufacturing batch records to ensure completeness, accuracy, and compliance with cGMP.

• Bachelor’s degree in a relevant life science field (e.g., Biology, Chemistry) preferred with 0‑2 years of relevant QA experience in pharmaceuticals, preferably in an FDA‑regulated manufacturing facility.
• Ability to read, analyze, and interpret scientific and technical journals, financial, and legal documents.
• Ability to respond to inquiries or complaints from customers, regulatory agencies, or the business community.
• Ability to present information to top management.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret technical instructions in mathematical or diagram form and manage multiple variables.
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint).
• Demonstrated ability to work under aggressive timelines and manage time effectively.
• Excellent oral and written communication skills.
• Strong training and presentation/facilitation skills.
• Analytical, critical thinking, and decision‑making skills.
• Independence and teamwork.
• Knowledge of GMP procedures, documentation practices, GMP regulations, and radiopharmaceutical manufacturing.
• Other duties as assigned.

• Employees must permanently reside and work in the State of Texas.

The work environment includes manufacturing, laboratory, and office spaces. The position may require more than forty hours per week and is paid hourly. Work hours are typically from 8:30 AM to 5:00 PM. Individuals will be exposed to ionizing radiation; radiation safety training and monitoring are provided continuously, within Federal and State limits. Candidates must be able to function and maneuver safely in the work environment.

Referral program:
Referrals increase your chances of interviewing with Radiomedix, Inc. by 2x.