Quality Control Material Specialist I

Job Code:

Q1077

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JOB DESCRIPTION

This is an Entry Level Materials Specialist in the Quality Control Operations (QCO) group.

Matica Biotechnology is currently offering a unique opportunity for a highly motivated QC professional to join our team with expertise in QC material management. The individual will be responsible for assisting in all daily activities within the QC Operations Department including but not limited to the following:

RESPONSIBILITIES

  • QCO Department is responsible for the following activities:

    • Sample Scheduling

    • Scheduling in LIMS

    • Accessioning QC samples from Manufacturing

    • Stability Program sampling

    • Raw Material Sampling

    • Organization and inventory of all samples including but not limited to retain and reference samples.

    • Preparing Outsourced QC Testing

    • Creation of all Material Specifications

    • Assisting in activities related to handling and processing of all GMP and Non-GMP material.

  • Incumbent will also be expected to perform the following duties:

    • Assisting in writing/creating Standard Operating Procedures (SOPs)

    • Participate in Method Transfer activities.

    • Participate in internal audits, client audits and agency inspections of the site.

    • Maintain training requirements for all Quality Control Operations processes.

    • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.

    • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.

    • Maintain a high level of integrity and professionalism when interacting with coworkers and clients.

    • Other duties as assigned by the Quality Control Operations Supervisor.

  • Incumbent must exhibit the following characteristics

    • Ability to communicate and work in a fast-paced team environment.

    • Ability to work both independently and in a team-oriented environment.

QUALIFICATIONS

  • Preferred but not required AS/AA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.

  • 0-2 years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.