Location: Indianapolis
Job Summary
The Technical Support Specialist will be responsible for leading the investigation of manufacturing deviations and driving continuous improvement initiatives resulting from manufacturing deviations. The Technical Support Specialist will work with subject matter experts and area owners to drive comprehensive root cause analyses and identify CAPAs. The Technical Support Specialist will work cross functionally to meet product release and quality timelines related to the investigations, CAPAs, and continuous improvements.
Key Responsibilities:
- Apply technical knowledge and abilities to investigate manufacturing deviations
- Review data and documentation to support investigations
- Participate and drive projects and continuous improvement efforts
- Develop and implement CAPAs from root cause analyses and manufacturing deviations
- Draft GMP documentation including but not limited to SOP’s, Forms, Deviations, CAPAs, change Controls and reports.
- Support Health Authority Inspections
- Maintain department KPIs related to performance and throughout of GMP manufacturing deviations and CAPA
- Provide support executing equipment and process validations as necessary.
Education and Experience:
- BS or MS in scientific related field or equivalent work experience
- 1-5 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
Skills and Qualifications:
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Good technical writing skillset
- Must possess an independent mindset and tenacity
- Highly motivated and organized professional with strong interpersonal and communication skills.
- Proven experience working with teams in a GMP environment.
Please click here to apply.
