Radiomedix, Inc. · 1 month ago
Quality Assurance Associate
Houston, TX
Full-time
Onsite
New Grad, Entry Level
0+ years expRadioMedix Inc. is a Contract Manufacturing Biotechnology Company seeking a Quality Assurance Associate to work in radiopharmaceutical manufacturing. The successful candidate will conduct Quality Assurance reviews, support Quality Systems functions, and oversee operations related to validation and manufacturing processes.
BiotechnologyHealth Care
Responsibilities
Supports Quality on the Floor activities within a cGMP Operations in a 21 CFR 211 facility
Support the initiation and assignment of Quality Events such as (Deviations, CAPAs, Out of Specifications (OOS)
Perform release of quarantined raw materials. Identify and assist in resolving issues related to the quarantine/rejection of materials
Completes documentation in accordance with GDP
Review executed records for GMP support areas to include facilities maintenance, materials management records and QC laboratory maintenance
Prepare and file all executed documents for archiving per standard operating procedures
Review training records and ensure training documents are filed and maintained files are up to date
Review equipment maintenance records and ensure equipment files are up to date
Assist in training staff in quality procedures
Prepare records for off-site record storage
Maintain and update tracking databases as required
Performs real time review of manufacturing batch records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements
Qualification
Required
Bachelor's Degree in a relevant life science field (e.g., Biology, Chemistry) preferred with 0-2 years of relevant Quality Assurance experience in pharmaceuticals, preferably working within an FDA regulated manufacturing facility
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to top management
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint
Demonstrated ability to work under aggressive timelines, demonstrated time management skills
Demonstrated excellent oral and written communication skills
Demonstrated solid training and presentation/facilitation skills
Demonstrated analytical, critical thinking and decision-making skills
Demonstrated ability to work effectively and independently
Demonstrated knowledge of procedures, documentation practices, GMP's and regulations associated with the manufacture of radiopharmaceuticals
Employees must permanently reside and work in the State of Texas
Company
Radiomedix, Inc.
RadioMedix, Inc.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$40MKey Investors
Portland Investment Counsel
2022-10-07Series A· $40M
Recent News
2025-12-05
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