LOTTE BIOLOGICS located in East Syracuse, NY is seeking a Document Control Coordinator to join our team who entered the biologics Contract Development Manufacturing Organization (CDMO) business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, on January 1, 2023!

The Document Control Coordinator is responisble for facilitating and executing 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.

• 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.

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.

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

http://www.lottebiologics.com/

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.