Quality Assurance Specialist

7 hours ago


Suzhou, Jiangsu, China Lilly Full time

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Lilly. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and processes.

Job Description

The primary responsibility of this role is to provide secondary loop QA support across packaging process teams for East Lake Packaging, including regular participation on process teams as needed, supporting investigations for GMP-related incidents, coaching and mentoring primary and zero loop QA personnel, participating in self-led and/or agency inspections, and reviewing and red-lining GMP documents.

You will also be responsible for supporting process design, qualification, and validation, which includes reviewing and approving user requirements, technical specifications, qualification packages, process flow documents, and other documentation. Additionally, you will ensure that design, qualification, validation, and documentation are in compliance with GMPs.

As part of this role, you will participate in qualification execution, including FATs, IQ, OQ, PQ, and process validation, as required. You will also support product batch release, including reviewing batch records, issuing product conformity certificates, maintaining finished product quality specifications, and performing implementation steps for changes related to product release.

Required Skills and Qualifications

To be successful in this role, you will need to have an educational qualification of an undergraduate course or above in pharmacy, chemistry, biology, or a related science. You must also be proficient in using applicable computer systems and demonstrate strong oral and written communication skills.

Furthermore, you will need to demonstrate interpersonal skills and the ability to work as a team, as well as root cause analysis and troubleshooting skills. Attention to detail and the ability to maintain quality systems are also essential.

Fluency in English is required, and we value diversity and inclusion in the workplace.

Benefits

Lilly offers a competitive salary range of $80,000 - $110,000 per year, depending on experience. We also offer comprehensive benefits, including health insurance, retirement plans, and paid time off.

In addition to these benefits, we offer opportunities for professional growth and development, as well as a collaborative and inclusive work environment.



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