Radiomedix, Inc.
Overview
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 work 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. 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, and 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. 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. Qualifications
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 inquiries 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 a variety of technical instructions in mathematical or diagram form and deal with several variables. Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint. Demonstrated ability to work under aggressive timelines, with strong time management skills. Excellent oral and written communication skills. Solid training and presentation/facilitation skills. Analytical, critical thinking and decision-making skills. Ability to work effectively and independently. Knowledge of procedures, documentation practices, GMPs and regulations associated with the manufacture of radiopharmaceuticals. Other duties as assigned. Residency
Employees must permanently reside and work in the State of Texas. 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 hourly. The work period is typically between 8:30 AM to 5 PM. Individuals in this position will be exposed to ionizing radiation; 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Wireless Services, Telecommunications, and Communications Equipment Manufacturing Note: This listing has been reformatted for clarity and compliance with described formatting standards.
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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 work 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. 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, and 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. 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. Qualifications
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 inquiries 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 a variety of technical instructions in mathematical or diagram form and deal with several variables. Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint. Demonstrated ability to work under aggressive timelines, with strong time management skills. Excellent oral and written communication skills. Solid training and presentation/facilitation skills. Analytical, critical thinking and decision-making skills. Ability to work effectively and independently. Knowledge of procedures, documentation practices, GMPs and regulations associated with the manufacture of radiopharmaceuticals. Other duties as assigned. Residency
Employees must permanently reside and work in the State of Texas. 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 hourly. The work period is typically between 8:30 AM to 5 PM. Individuals in this position will be exposed to ionizing radiation; 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Industries
Wireless Services, Telecommunications, and Communications Equipment Manufacturing Note: This listing has been reformatted for clarity and compliance with described formatting standards.
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