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Senior Quality Assurance Associate
RadioMedix, Inc.United Statesfull_timeVerifiedPosted 1 Jul 2025
About the role
RadioMedix Inc., a Contract Manufacturing Biotechnology Company located at 19705 Aldine Westfield Rd. Humble, TX 77338, is seeking a Senior Quality Assurance Associate (Operations) to work in radiopharmaceutical manufacturing. The successful candidate will play a key role in conducting Quality Assurance review of all drug products on-site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. The Quality Assurance Specialist I (Operations) role will be responsible for providing oversight over operations which includes validation and manufacturing operations. This role supports Quality Systems functions and operations.
We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape.
Roles/Deliverables
We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape.
Roles/Deliverables
- 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.
- Bachelor’s Degree in a relevant life science field (e.g., Biology, Chemistry) preferred with 2-4 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
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