Quality Assurance Validation Analyst at LOTTE BIOLOGICS - MACNY's Job Board
East Syracuse, NY 13057
About the Job
We are LOTTE BIOLOGICS! A new company, built on 80 years of tradition!
We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
We deliver therapies that make a Healthier World!
Responsibilities:To help us meet our mission LOTTE BIOLOGICS is in need of a QA Validation Analyst who will be responsible for the validated state of the equipment, instruments and automation in manufacturing facilities. This role will ensure that all regulatory and cGMP compliance items are satisfied.
Duties/Responsibilities:
- Provides quality oversight on the validation of equipment, instruments and automation in the manufacturing and laboratory facilities.
- Provides quality oversight on the validation of process utilities.
- Quality Approver on installation qualification, operational qualification and performance qualification protocols and reports for equipment, instruments and automation in manufacturing and laboratory facilities.
- Contributes to the creation of team based, collaborative environment promoting candor and receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
- Identifies issues within and outside area of responsibility. Evaluates options and presents solutions to manager. Leads efforts to resolve the issue.
- Will cross train and develop their expertise in other areas of validation such as method validation, process validation, etc.
Education/Experience/ Licenses/Certifications:
Bachelor of Science in Microbiology, Biotechnology, Chemical Engineering or scientific field having 5+ years’ experience in pharmaceutical manufacturing of biologics or aseptic filled products OR a MS with 2-4 years relevant experience.
Specific Knowledge, Skills, Abilities, etc:
- Personnel must have knowledge and experience of any of the following: operation and validation of processing equipment, operation and validation of process control systems (DCS and PLC). Validation of Laboratory equipment and instruments including Computer System Validation.
- Knowledge of FDA, EU and ICH regulations, guidance, and cGMPs for biopharmaceuticals
- Must have effective verbal and written communication skills.
- Must demonstrate multitasking and organizational skills.
- Must be able to interact and lead effectively in a team-based environment.
- Attention to written detail is essential.
Work Environment:
- Office Space with sitting, bending, stooping, twisting. Role will require repetitive use of arms, hands and wrists as frequent computer usage while reviewing documents. Most time will be spent at the computer reviewing documents.
- Working with/around others - will be in a shared working space
- This position is a team-based position that may require weekend, holiday, and off-shift coverage when necessary
- Entering the laboratory and manufacturing floor environments to perform quality oversight activities may be required and PPE will be required.
Work Location:
East Syracuse, NY
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities. If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
Company Website:
http://www.lottebiologics.com/
Company Profile:LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!
The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry. With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.
An Equal Opportunity Employer
We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.