Highly Skilled IT Professional for GxP System Implementation
3 days ago
We are seeking a highly skilled IT professional to join our team as a Senior Systems Analyst, Quality Information Technology (QIT) in New Albany, OH. As a key member of the Quality IT department, you will be responsible for leading GxP system implementation and providing data integrity and regulatory guidance and oversight throughout the system lifecycle.
About Us:
At AmplifyBio, we are committed to growing and empowering an inclusive community within our company and industry. We value diversity at our company and do not discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to enhance our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own. Some benefits include:
- Health, Dental, and Vision insurance that starts on your first day
- Competitive Compensation Package ($115,000 - $140,000 per year)
- FLEXIBLE PTO policy
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyone's voice matters.
What We Are Looking For:
We are looking for a highly skilled IT professional with a minimum of 5 years of experience in data integrity requirements and GxP computer system validation. You should have in-depth knowledge of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas. You should also have cross-functional experience in QC, QA, Validation and Manufacturing. Additionally, you should have technology skills and experience supporting Linux/Windows OS, cloud infrastructure and basic LAN/WAN architecture. If you are a strong leader with excellent interpersonal skills, including written and verbal communication, then we would love to hear from you.
About the Role:
The Senior Systems Analyst, QIT will report to the Quality IT Manager for the GMP manufacturing site. This is an on-site role based at our GMP manufacturing site located in New Albany, OH. Being a member of the cross-site QIT team, the incumbent will be expected to support other sites as needed.
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