Overview
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 Document Control Coordinator to facilitate and execute the initiation, processing, routing, distribution and archiving of cGMP records in accordance with internal and external regulations, policies, and procedures utilizing appropriate electronic systems.
Perform all routine activities associated with the document change management system.
Support the revision and creation of GMP documentation through the document change process. This includes, but is not limited to, performing routing, document processing, and formatting of documents.
Perform all routine activities associated with manufacturing batch record issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks which will require work inside classified manufacturing areas.
Perform all routine activities associated with laboratory documentation issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks.
Assist with the records management program, including interim and archival activities as well as facilitate shipments to Iron Mountain.
Assist in the management and retention of documentation in accordance with records retention schedules in conjunction with legal hold notices
Perform document storage room activities such as filing, organization, barcoding in RMS and escorting personnel into the room.
Remote Position
No
Min Compensation
USD $25.48/Hr.
Max Compensation
USD $36.89/Hr.
Bonus
5%
Qualifications
Education/Experience: High School diploma required, a college degree preferred with a minimum of 2 years experience.
Controlled documentation experience preferred.
GMP experience preferred.
Working knowledge of common computer systems such as Microsoft Office is preferred.
Specific Knowledge, Skills, Abilities, etc: Excellent organizational skills and attention to detail in a fast-paced environment.
Flexibility and capability of multitasking
Excellent oral and written communication skills
Excellent computer competence.
Effective interaction with all contacts is required.
Must also exercise sound judgment in assuring compliance with Regulations.
Self-directed with ability to take initiative and follow through to completion on commitments.
Ability to create effective change in a team based collaborative environment.
Physical Demands:
Primarily an office-based position with filing requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists and reaching. Must be able to lift up to 20 lbs.
Work Environment: Primarily an office-based position with entry into manufacturing and warehouse facilities within classified areas requiring appropriate levels of PPE. May also require entry into laboratory spaces that require appropriate levels of PPE.
Entry into manufacturing area will require special gowning including removal of all makeup, jewelry and nail polish. Only plain wedding bands are allowed.
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.
