Location: Indianapolis, IN
Job Summary
Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required in a multi-phase and commercial radiopharmaceutical facility. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Key Responsibilities:
- Quality floor support of complex manufacturing activities, including line release, alarm review, logbook review, etc. Gowning is required when working in ISO classified spaces.
- Build and maintain cross functional relationships to improve processes, resolve issues, and facilitate uniform quality standards
- Performs walkthroughs of GMP areas documenting observations and areas of concern
- Performs training on routine facility Quality tasks for new team members
- Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs
- Assures all electronic and paper documentation, which requires QA review is in compliance with site procedures and protocols, cGMP regulations, and other industry guidelines
- Authors and revises Quality-specific SOPs and may provide Quality review and approval of manufacturing related SOPs
- Supports the Quality review and closure of manufacturing deviations, corrective and preventative actions, and change controls, including evaluation of root cause analyses, as well as impact and risk assessments
- Supports the Quality review and closure of Out-of-Specification results and Lab Events identified during Quality Control testing of raw materials and manufactured drug products
- Supports release of incoming raw materials
- Other duties as assigned
- No travel required
Education and Experience:
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred, advance degree a plus.
- A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on quality preferred.
- Knowledge of late phase and commercial GMP aseptic manufacturing, analytical and Microbial testing is highly desirable.
- Knowledge of US and EU cGMP regulations.
- Knowledge of electronic or paper batch record systems and other electronic systems applicable to laboratory test result generation, investigations, inventory management, and equipment tracking and maintenance is desirable.
- ASQ or ISO certification a plus/
Skills and Qualifications:
- Highly motivated and organized professional with the ability to work independently
- Working knowledge of 21 CFR Parts 11, 210, 211 and EU regulations
- Personable with strong communication skills and ability to multi-task
- Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory and ISO classified environments with radioactive materials, where protective clothing, gloves, and safety glasses may be required.
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