Req#: S8hb5L2sGjD2Employer Industry: Pharmaceutical Manufacturing
Why consider this job opportunity:
- Opportunity for contract work with a duration of 3 to 4 months
- Hybrid work option available, providing flexibility between onsite and remote work
- Work in a dynamic team environment focused on innovative solutions
- Engage in meaningful work that impacts the production of radioisotope products
- Collaborate with peers and external customers to enhance quality assurance practices
What to Expect (Job Responsibilities):
- Interpret quality assurance requirements from regulatory guidelines and apply them in work procedures and documents
- Review production batch records and approve radioisotope products for distribution
- Develop technical procedures and documents while implementing QA requirements
- Maintain up-to-date regulatory filings with agencies, including a Drug Master File
- Conduct cGMP training and assist in non-conformance processing
What is Required (Qualifications):
- Bachelor's degree in Science, Quality Assurance, or a related field
- Minimum of five years of relevant quality experience
- Working knowledge of current Good Manufacturing Practices (cGMP) for drug manufacturing
- Ability to obtain and maintain a clearance from the Department of Energy
- Must pass a pre-placement drug test as this is a Workplace Substance Abuse (WSAP) testing designated position
How to Stand Out (Preferred Qualifications):
- Strong computer and organizational skills with multitasking ability
- Experience with quality-related analytical methods such as gamma spectroscopy
- Background in radioisotope production and facility design for manufacturing
- Knowledge of radioactive decay calculations
- Proven track record of collaborating with internal and external organizations
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