Job Description
Quality Assurance Associate sought to support the development and implementation of digital technologies in a cutting-edge biotechnology company.
We are a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies.
The ideal candidate is an organized and methodical professional who fosters a positive team environment and has a minimum of 5 years' experience in GMP operations, IT management, or technology integration roles, preferably within the biotech or pharmaceutical industry.
Main Responsibilities:
- Coordinate the site program to ensure compliance with the Global Quality Standards.
- Drive efficiencies in the process.
- Report and escalate critical quality issues related to monitoring of quality systems, verification of the effective implementation of key GMP programs, and reviews of systems that impact safety, product quality.
- Translate business needs into user requirements for all new digital technologies & solutions in Quality Assurance.
- Coordinate and report site compliance information and management review reports.
- Coordinate and support Change Management, Trending and activity planning business process owners.
- Interpret and apply emerging Global Quality System changes, Regulatory & GMP guidelines to the specific Quality System(s)/Program.
- Generate and report metrics such as observation metrics, backlog metrics, change control metrics to senior management.
- Develop the standard workflows for how we will use digital technology within our QA processes and operations.
- Support strategies for operational offline and online shakedown and testing of digital solutions post-implementation by IT.
- Liaise with operations and IT to develop best training practices to ensure an efficient, effective, and timely knowledge transfer to the end users.
- Support the implementation of these digital solutions.
- Develop the user requirements for the site's Data Collection and Data Analytics needs.
- Lifecycle owner for the Quality Assurance function's Digital roadmap.
- Stay abreast of industry trends and advancements in digital technologies to continuously improve the company's digital capabilities.
- Support site GMP inspections ensuring appropriate technical resources are identified to support inspections.
Requirements:
- BSc (Level 8 Degree Minimum), MSc, or Ph D in Biotechnology, Chem, Eng or related discipline with appropriate experience.
- Personal considerations: The role operates on a standard working week.