Job Description

This company is the world’s largest nuclear medicine company with more than a century of industry experience. They develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. They delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. Currently they are looking to expand the Indianapolis operation by adding a Sr QC Technician and Sr QA Technician to their team.

Summary of Position:
The Quality Assurance Specialist position reports directly to the Manager Quality Assurance. The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.

Essential Functions:

• Write, revise, review, and approve site procedures and policies.
• Review and approve investigations and associated CAPAs.
• Participates in regulatory agency (i.e. FDA, etc.) inspections.
• Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.
• Assemble, analyze and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.
• Review Batch Records and provide final product disposition.
• Conducts internal audits of GMP Quality Systems and sub systems.
• Aide in assessing risk during Vendor Qualifications or Material Assessments.
• Conducts incoming material disposition.
• Document Control, Training, Quality Systems back-up and key trainer.
• Reviews and assesses in-house solution preparation and external material testing.
• Conducts Vendor Qualification and reviews.
• Review and compile the Annual Product Quality Review.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.

Additional Skills & Qualifications

Must Haves:
1) Bachelor's or Master's Degree in Life Science
2) 3 years of relevant GMP QA experience (Most must be from pharma)
3) Strong experience with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.

Plus:
1) Method development/validation experience
2) Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred
3) Any radiopharma experience is highly valued

Job Type: Full-time

Pay: $34.00 - $37.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years
• 4 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Noblesville, IN 46060: Relocate before starting work (Required)

Work Location: In person