Global Quality Assurance Specialist

3 weeks ago

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

In this role as a Quality Auditor, you will play a vital part in ensuring the quality and compliance of our operations within the pharmaceutical industry. You will be responsible for conducting internal and external audits to assess our compliance with regulatory requirements and industry standards. This position is ideal for a detail-oriented individual with a strong understanding of quality assurance principles and regulatory requirements.

Key Responsibilities

- Conduct quality audits and assessments of research and commercial operations to ensure compliance with company standards, policies, and procedures.
- Schedule, prepare, conduct, and report on audits and assessments, both internally and externally (contracted) to assess the level of compliance with company standards, policies, practices, and procedures and current regulations and guidelines.
- Lead audit teams, including GXP, and successfully execute a portfolio of complex audits as lead or solo auditor, as appropriate (e.g., for cause, process, and system audits, affiliates, large TPOs, and pre-inspection audits).
- Participate in mock-inspections, as appropriate, and participate in or lead the risk assessment of research and commercial operations.
- Integrate information obtained through auditing and risk assessment and influence actions within and across GQAAC and the business areas involved/impacted.
- Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.

Requirements

- Bachelor's Degree (or equivalent work experience) in physical or biological sciences, Engineering, or other technical area.
- Relevant GCP experience (minimum of 7 years) at Lilly or within the Pharma environment.
- Experienced in working with Third Party Organizations.

Preferred Qualifications

- Auditing and/or quality experience.
- Experience with computers, entering, and managing data in databases.
- Ability to successfully handle several complex projects in parallel.
- Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations, and identify and recommend compliance changes as appropriate.
- Ability to analyze detailed technical scientific information, while understanding the bigger picture.
- Ability to work under pressure on multiple tasks concurrently and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities.
- Ability to think on your feet and be pragmatic in decision-making and analytical/problem-solving skills.
- Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.

About Us

BioSpace, Inc. is a global healthcare leader headquartered in Indianapolis, Indiana. We unite caring with discovery to make life better for people around the world. We are committed to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Our employee resource groups offer strong support networks for their members and help our company develop talented individuals for future leadership roles. 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.

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