Job Description

Quality Control Specialist needed!

Overview:

The Quality Control Specialist II – Sample Management will ensure time-sensitive distribution of quality control samples in support of QC-related activities. They will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping under appropriate conditions, for all of the cell therapy asset.

The weekend position is either a Sunday to Wednesday or Wednesday to Saturday shift with a 9am-7pm schedule.

Essential Functions and Responsibilities:

• Manage all aspects of QC sample logistics for raw material, in-process, and final product samples including sample storage, sample inventory and reconciliation, scheduling, and shipping in LIMS based system.
• Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP
• Provide timely distribution of samples internally and externally to testing vendors
• Ensure that sample inventory records are maintained and accurate
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the logistics function remains in compliance with applicable requirements.
• Support audits and inspections as needed.
• Packaging of samples using temperature controlled dewars, cold packs, and dry ice.
• Support ramp up of Quality Control and other activities in a newly built facility.

Required Education, Skills, and Knowledge:

• Associate degree or 3+ years of relevant GMP experience (sample management)
• Experience with inventory and/or logistics in the pharmaceutical industry
• Detail-oriented with strong mathematical skills
• Excellent written and verbal communication skills
• Strong collaboration, time management, and organizational skills are required
• Proven ability to effectively collaborate with a wide range of stakeholders
• Excellent judgment and creative problem-solving skills
• Ability to work in a fast-paced and dynamic environment
• Hands-on laboratory experience with sample handling, inventory, and cryo-shipping
• The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

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