Job Description

Quality - Supply Chain Operations Associate

Job Description: Work location: Devens, MA

100% onsite role

Shift Time: Mon thru Fri 7:00am to 3:30pm or 8:00am to 4:30pm

Top 3 to 5 Skills/Must Haves:

SAP knowledge - inventory management/transactional

Strong Operational/Manufacturing Skills

GMP experience

PURPOSE AND SCOPE OF POSITION:

The role is responsible for providing on the floor support and participate in materials management activities across the Cell Therapy Facility, specifically focusing on patient material receipt and shipments.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Proficiency in MS Office applications
• Knowledge of cGMP/Pharmaceutical regulations
• Excellent written and verbal communication skills
• Demonstrated experience to
• Effectively communicate problem statements and escalate concerns
• Present data and analyses in an organized, clear and concise manner
• Coach less experienced group members
• Work independently for extended periods of time

DUTIES AND RESPONSIBILITIES

Responsibilities will include, but are not limited to the following:

Operation

• Execute daily tasks for material receipt and shipments according to the schedule
• Adhere to safety, quality, and productivity standards in all material operations
• Maintain a safe work environment in all areas where material operations activities occur
• Collaborate with cross-functional team members to solve work-related problems and perform routine activities
• Identify and report any changes needed in documentation and equipment as part of continuous improvement efforts

General Work Activities

• Partner with Cell Therapy Manufacturing & Quality to support the readiness for prompt receipt, inspection and start of processing for patient material
• Coordinate, pack & ship materials to both domestic and international markets, including hazardous materials
• Adhere to good manufacturing practices and standard operating procedures
• Support in maintaining material inventory accuracy using required systems and equipment
• Support process investigations & CAPAs
• Provide support and suggestions on special projects such as validation of Material Operations areas

Document & Work Review

• Assist in reviewing area documents, such as logbooks & worksheets.
• Review work throughout the work process and at completion, in order to ensure that it has been performed properly, where ability to recognize deviation from accepted practice is required
• Verify SAP transactions of inventoried materials and their movements. Troubleshoot inventory/transaction errors.

EDUCATION AND EXPERIENCE

• High school Diploma / GED.
• Additional post-secondary education resulting in an Associate’s or Bachelor’s Degree in a relevant discipline is preferred
• An equivalent combination of education, experience and training may substitute
• Preferred but not required: Certification in CPIM, CSCP, and/or CLTD
• Minimum 4 years of experience in warehousing (preferably GMP) or performing material operations activities
• Experience working with production and ERP systems is highly preferred (SAP, MES etc)
• Experience with Liquid Nitrogen handling preferred

WORKING CONDITIONS:

• Operate in a GMP warehouse environment & gown into GMP clean room areas
• Don Personal Protective Equipment (PPE) as required by procedures & signage. May come in contact with hazardous material requiring additional PPE including respiratory protection (employee must be physically capable to wear a respirator)
• May be required to work alternate shift schedules, including shift or weekend coverage
• Operate motor vehicles including, 24 ft box trucks, fork lifts and other motorized material handling equipment
• Perform material picking activities at heights of up to 25 ft with required fall protection
• Perform activities as physical job, where employee may have to lift as much as 50 pounds and regularly bend reach & walk

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