• Quality Assurance Associate I - Raw Materials

    Location US-MD-Columbia
    Job ID
    2018-1272
    # Openings
    1
    Category
    Quality Assurance
  • Primary Purpose of Position

    The primary purpose of this position is to review, inspect, and disposition incoming raw materials for QA, processing of rejected lots out of inventory, processing of returned goods for QA.  The secondary purpose of this job is to process document changes for material specifications and process supplier qualification documentation for new and existing suppliers

    Principal Responsibilities

    • Review, inspection, and disposition of all incoming raw materials for use in tissue product manufacturing.
    • Processing, inspecting, and rejection of tissue products out of inventory.
    • Processing, inspecting, and disposition of returned tissue products.
    • Performing QA end labeling activities in conjunction with manufacturing, as needed.
    • Processing of document change control paperwork for material specifications.
    • Initiation, review, and approval of supplier qualification documentation for new and existing material suppliers.
    • Scanning, filing and archival of QA related documents.

     

    Qualifications

    • A basic understanding of Good Manufacturing or Tissue Practices (GMP, GTP) and Quality Systems.
    • Ability to work independently in fast-paced environment with minimal supervision.
    • Ability to maintain focus and prioritize appropriately within processes that may change direction quickly.
    • Ability to pay continuous attention to detail, including documentation of procedural details when performing repetitive critical tasks.
    • Excellent interpersonal and communication skills inside and outside of the home department.
    • Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.
    • Required: A minimum of 1 year of experience in a regulated biotechnology or pharmaceutical environment (GMP, GTP).
    • Required: BS or BA in Life Sciences or related science based field.                                                         
    • Preferred: A minimum of 1 year of experience in performing material handling, inspection, and review at a regulated biotechnology or pharmaceutical company.
    • Preferred: A minimum of 1 year of experience in Quality Control or Quality Assurance performing material testing or documentation review at a regulated biotechnology or pharmaceutical company.

    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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