Quality Assurance Specialist

4 weeks ago


Indianapolis, Indiana, United States BioSpace, Inc. Full time

We are seeking a highly skilled Quality Assurance Specialist to join our team at BioSpace, Inc. in a role that will provide support to the Parenteral Products materials management systems.

This position will be responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

The ideal candidate will have demonstrated relevant experience in a GMP facility, proficiency with current computer systems and applications, and strong oral and written communication and interpersonal skills.

Responsibilities will include coordinating the appropriate tasks to maintain the Approved Supplier List, conducting material and supplier risk assessments, and providing input, guidance, and recommendation for Supplier / Service Provider approval and certification activities.

The successful candidate will be able to perform materials LMS data steward functions, review and Redline GMP documents, and provide procedure ownership and subject matter expertise as necessary.

This role will also involve providing the voice of quality to the Parenteral Supplier Committee, supporting regulatory inspection activities, and tracking and reporting materials management metrics.

Additional responsibilities may include leading local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.

Key qualifications for this role include a Bachelor's Degree or equivalent experience in a science-related field, experience with Lilly deviation and change control processes, and experience in material management, quality systems, and cGMPs.

We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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