Material Operations Associate II (2nd shift) - LOTTE BIOLOGICS USA, LLC

Position Summary

The primary role of the Material Operations Associate II is working on assignments that train for proficiency in the areas of material handling within Material Operations functions (Warehouse, Dispensary and Cryogenics) including adherence to detailed procedures and batch records ensuring compliance with cGMP and safety requirements. 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 classified areas and maintaining clean hygiene is a requirement to control established environmental specifications.

Duties & Responsibilities

• Fully trained and proficient in all aspects of Material Operations Associate I role.
• Recognizes and reports safety, maintenance and quality events to area management. Use of all appropriate PPE and perform required STOP observations. Promote a safe work environment including ensuring safety requirements are followed by all and using the appropriate safe reporting systems to raise concerns.
• Safe operation of all Material Operation Powered Industrial Equipment including site delivery vehicles and refueling practices as applicable, maintain OSHA certification, and performs daily inspections.
• Communicates status of operations to area management in a timely manner.
• Maintain cGMP compliant working environment, including material handling/processing equipment, specific cleaning responsibilities of equipment/areas, 5S of all working areas.
• Achieves proficiency through training and maintains training requirements for job functions at all times.
• Follow daily schedules, SOPs, and MBRs as applicable to perform daily job functions in a proficient manner. Be able to identify variances within the operation and escalate appropriately.
• Proficient in use of SAP and able to troubleshoot transactions pertinent to related job function.
• Able to call in work order as directed, Delta V capable, ability to understand and acknowledge alarms as well as appropriate alarm response.
• Proficient in ship/receive, thaw/mix, freeze activities for DS & samples, cryoshipper processes (Cryogenics).
• Proficient in dock, transfer, inventory roles (Warehouse).
• Proficient in dispense and 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 1-2 years related experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.

Knowledge, Skills & Abilities

• 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.
• 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

10%

Target Bonus

5%