MANUFACTURING OPERATOR – BIOSURGERY

US-MD-Columbia
Job ID
2017-1208
# Openings
3
Category
BioSurgery- Manufacturing Operations

Primary Purpose of Position

Provide support to manufacturing activities in clean room by supplying raw material, general supply material, and equipment as necessary

Prior clean room, aseptic technique, and/or experience in a pharmaceuticals manufacturing setting involving inspection, labeling, and packaging of finished product.

In depth understanding of good documentation practices

 

 

Osiris Therapeutics is a developer, manufacturer and distributor of regenerative tissue based products. In Biosurgery, we harness the ability of cells and novel constructs to promote the body's natural healing. The goals are to improve surgical outcomes and offer better treatment options for patients and physicians. We like a challenge, so the focus is in areas where we believe we can have a significant impact.

 

PRIMARY PURPOSE OF THE POSITION:

Responsible for hands-on execution of activities surrounding final packaging of product units outside the cleanroom; label acceptance, usage, reconciliation, and storage; equipment preparation; and inventory and material stocking in the Biosurgery manufacturing area. All duties performed in compliance with GMP/GTP, American Association of Tissue Banks Standards, and Osiris Standard Operating Procedures (SOPs). The candidate should have a commitment to high standards of quality.

Principal Responsibilities

  • Perform visual inspection, labeling, final packaging and storage of human tissue based product units in compliance with cGMP and company procedural requirements
  • Provide support to manufacturing activities in clean room by supplying raw material, general supply material, and equipment as necessary
  • Utilizing good documentation practices complete timely and accurate documentation of work performed in batch production records, supporting documentation and equipment logbooks
  • Complete inventory transaction in ERP system against work order
  • Perform visual inspection, steam sterilization, storage and post use reconciliation of product labels within manufacturing
  • Disinfect, wash, sanitize, and wrap equipment in preparation for autoclaving following standard operating procedures
  • Operate steam sterilizer according to standard operating procedure
  • Build equipment kits using sterilized equipment
  • Maintain equipment inventories to allow uninterrupted manufacturing operations
  • Monitor availability of material in General Supply Inventory. Request and restock materials
  • Identify processing and/or documentation improvement to further improve product quality or processing efficiencies
  • As necessary perform cleaning of Cleanroom to support manufacturing operation
  • Assist with preparation of raw materials for sterilization as required
  • Proactively identify potential issues and propose subsequent solutions
  • Timely reporting of equipment malfunction to manufacturing management
  • Other duties as assigned by manufacturing management which contribute to the overall success of the site

Qualifications

MINIMUM QUALIFICATIONS:

    • Associate’s degree in a relevant scientific discipline and 1-2 years of relevant manufacturing experience in FDA regulated, controlled production environment or
    • High school diploma and 2-3 years’ relevant experience manufacturing experience in a FDA regulated, controlled production environment
    • Attention to detail and ability to perform thorough documentation is required
    • Technical accuracy and ability to perform mathematical calculations
    • Strong interpersonal skills and the ability to work effectively and efficiently in a team environment
    • Excellent oral and written Communication skills
    • Must have the ability to work flexible schedules, including weekends, holidays, and overtime within a team environment.
    • Must be able to write effectively and be able to record data accurately and legibly.

PREFERRED QUALIFICATIONS:

      • Bachelor’s degree in a scientific discipline
      • Knowledge of GTPs, GMPs, and other applicable standards
      • In depth understanding of good documentation practices
      • Prior clean room, aseptic technique, and/or experience in a pharmaceuticals manufacturing setting involving inspection, labeling, and packaging of finished product.

Osiris Therapeutics, Inc. is an Equal Opportunity Employer with a commitment to diversity. Applicants are considered on the basis of individual merit without regard to race, color, national or ethnic origin, gender, gender identity, sexual orientation, marital status, veteran status, pregnancy, age, religion, disability, genetic information, or any other characteristic protected by law.

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