Quality Assurance Specialist I

Job Description

Job Description

RadioMedix Inc., a Contract Manufacturing Biotechnology Company located at 19705 Aldine Westfield Rd. Humble, TX 77338, is seeking a Quality Assurance Specialist I (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

• 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.

The Candidate

• 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.
• Other duties as assigned.

Work Conditions

The work environment consists of manufacturing, laboratory and office spaces. The position will sometimes require more than forty hours of work per week.

The position is paid as salary. The work period is typically between 8 : 30 AM to 5 PM.

Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities.

Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product or others at risk.

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