• Biotechnology, Document Control Coordinator

    Location US-MD-Columbia
    Job ID
    2019-1289
    # Openings
    1
    Category
    Quality Assurance
  • Primary Purpose of Position

    The primary purpose of this position is to issue batch production records and product labels to manufacturing in a timely manner to meet the production schedule.

    Principal Responsibilities

    • Assignment of product lot numbers and issuance and inspection of batch records associated with each manufacturing process.
    • Generation and inspection of complex product labelling for all products in current production, including the ability to identify minute defects on printed labels.
    • Generation of printing and inspection paperwork according to established procedures and good documentation practices.
    • Coordinating printing schedule based on production plan to ensure manufacturing operations are not halted through lack of batch records or product labels.
    • Scanning, filing, and archival of quality records.
    • Maintaining controlled area inventory, packing and verifying quality records to be sent to off-site storage.
    • Ability to maintain focus and prioritize appropriately within processes that may change direction quickly.
    • Good decision making and troubleshooting skills in relation to procedures, regulatory standards, and company policies.
    • 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 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.

    Qualifications

    Required:

    2 or 4 year college degree, preferably in a related science based field.

    • Required: 1 year of experience in a regulated environment (GMP, GTP).
    • Preferred: 1 – 2 years of experience performing document control functions or printing and inspecting large quantities of labels.
    • Preferred:  1 – 2 years of experience in a detail oriented inspection role of any kind

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