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We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
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.
Position Summary
The primary role of the Material Operations Associate III is following detailed procedures and batch records ensuring compliance with cGMP and safety requirements. The Material Operations Associate III works on assignments that are moderately complex in nature, where judgment is required in resolving problems and making routine recommendations. Work is performed in a team environment within multiple areas of the facility including unclassified and classified areas requiring appropriate personal
protective equipment (PPE). Additional gowning through the classified areas and maintaining clean hygiene is a requirement to control established environmental specifications. The Material Operations Associate III is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff.
Duties & Responsibilities
• Fully trained and proficient in all aspects of Material Operations Associate I and II roles.
• Act as Dedicated Trainer for all applicable processes.
• Perform supporting roles on shift for EHS, Quality, Maintenance, and Op Ex.
• Revises SOPs, MBRs, etc. Provides review on SOP and batch record revisions, DCRs.
• Oversee the accuracy and documentation of all area related processes.
• Ensure manufacturing processes are maintained in a compliant mode of operation, including adherence to written procedures and batch records.
• Proficient in general computer related activities, specifically SAP, to manage inventory accuracy and planning.
• Participating in routine inspections for safety, housekeeping, and compliance.
• Support QE investigations, CAPAs, and Validation activities as needed.
• Participate in maintenance, compliance, calibration, and cleaning processes.
• Support outside departments to perform required validations or qualifications of equipment or processes.
• Proficient for area specific Maximo, work order submission, advanced Delta V capable.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes
• Fully trained and proficient in all aspects of Material Operations Associate I and II roles.
• Act as Dedicated Trainer for all applicable processes.
• Perform supporting roles on shift for EHS, Quality, Maintenance, and Op Ex.
• Revises SOPs, MBRs, etc. Provides review on SOP and batch record revisions, DCRs.
• Oversee the accuracy and documentation of all area related processes.
• Ensure manufacturing processes are maintained in a compliant mode of operation, including adherence to written procedures and batch records.
• Proficient in general computer related activities, specifically SAP, to manage inventory accuracy and planning.
• Participating in routine inspections for safety, housekeeping, and compliance.
• Support QE investigations, CAPAs, and Validation activities as needed.
• Participate in maintenance, compliance, calibration, and cleaning processes.
• Support outside departments to perform required validations or qualifications of equipment or processes.
• Proficient for area specific Maximo, work order submission, advanced Delta V capable.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
• Lead specific area team huddles as required.
• Subject matter expert in ship/receive, thaw/mix, freeze activities for DS & samples, cryoshipper processes (Cryogenics).
• Subject matter expert in dock, transfer, inventory roles (Warehouse).
• Subject matter expert in dispense & sample activities (Dispensary).
Education & Experience
• The successful candidate will have a high school diploma or equivalent. Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired but not required.
• A minimum of 1-4 years related experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.
Qualifications
• Prior job-related experience required and high level of attention to detail.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• A well-rounded supply chain/material handling background within a regulated GMP environment, buffer/media make up or sampling background is preferred.
• Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical to success.
• Demonstrates good interpersonal skills, is attentive and approachable with the ability to embrace a team-based culture.
• Demonstrated ability to communicate expectations and results to the operating staff and management as needed to maintain production timelines and organizational goals.
Work Environment
• The work environment involves activities in a medium scale manufacturing facility, warehouse, dispensing, cryogenics and office space.
• The environment includes limited exposure to noise (> 85 dBA), hazardous chemicals and equipment temperature extremes.
Physical Demands
• This position is located in a medium scale manufacturing facility with unclassified and classified areas requiring appropriate personal protective equipment (PPE). This role will require contact with hazardous materials such as caustic, acids and extreme cold temperatures.
• Frequent bending, twisting, squatting, kneeling, climbing and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs.). Repetitive use of arms/hand/wrists, grasping is also required.
• This position is a team-based position that requires shift work, weekends, holidays and overtime.
Shift Differential
5%
New York Pay Range
$24—$33 USD
Work Location
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
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!
