Quality Assurance - Operational Support
$65k/y-$169k/y
3 days ago
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OnsiteFull-timeMid
Summary
BioSpace is seeking a Quality Assurance - Operational Support representative to join their team in Lebanon, IN. The role involves ensuring GMP compliance in the design, delivery, verification, qualification, and startup of manufacturing areas at Lilly's new facility.
About the Role
As a Quality Assurance - Operational Support representative, you will demonstrate leadership and quality knowledge to provide guidance and consultation during the design and startup of manufacturing areas. Your responsibilities will include acting as a cGMP liaison, participating in design reviews, providing quality oversight for equipment verification, and supporting the development of site quality operations.
About You
Required:
- Bachelor's degree in a relevant field (preference for scientific or engineering field).
- 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles.
- Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
Preferred:
- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing.
- ASQ Certified.
- Computer System Quality Assurance experience.
- Previous facility or area startup experience.
- Previous experience with gene therapy drug substance processes.
- Previous experience with lab equipment delivery and qualification.
- Previous experience with management of utilities, facilities, maintenance, and warehouse logistics.
- Previous experience with Manufacturing Execution Systems.
- Previous use of KNEAT or other electronic validation software.
- Demonstrated ability to communicate with and influence cross-functional teams.
- Demonstrated strong problem solving and decision making skills.
- Previous technical writing experience.
- Technical aptitude and ability to train and mentor others.
Benefits
- Competitive salary range of $65,250 - $169,400.
- Eligibility for a company bonus based on performance.
- Comprehensive benefits package including medical, dental, and vision coverage.
- 401(k) and pension plans.
- Vacation benefits and flexible spending accounts.
- Life insurance and well-being benefits.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
Lebanon, IN