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Materials Control Associate

Company: Paragon Gene Therapy, a unit of Catalent Biologics
Location: Baltimore
Posted on: September 14, 2019

Job Description:

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. This role is responsible for supporting the overall GMP materials control/warehousing operations for a Phase II/II GMP biopharma manufacturing facility. The position requires practical experience and knowledge of a variety of activities such as materials receipt/quarantine/release, logistical support in a manufacturing facility, electronic inventory control and distribution/shipping of products This is a first shift position Responsibilities include but are not limited to:

  • Conducts reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form)
  • Assessing the Materials Control operation on a continuing basis and providing recommendations for improvement is encouraged
  • Generation of GMP documentation (SOPs, etc.) is expected
  • Will participate in the receipt of all GMP materials - rectify discrepancies, matching vendors' documentation against Paragon requirements (GMP and accounting). Initiates appropriate documentation in a timely manner
  • Will distribute materials for GMP operations following approved procedures. This includes assisting in the reconciliation of all GMP materials after client campaigns
  • Compile and maintain inventory records
  • Takes receipt and inventory control of Paragon generated material (cell banks, bulk protein, etc.)
  • Assists with performing internal audits
  • Will participate in regulatory (FDA, EMEA) and client audits/inspections of Paragon and the facility
  • Works under general supervision to meet project goals
  • Works closely with QA to quarantine and release all GMP materials in a timely manner
  • Participation in the organization and cleanliness of the warehouse will be critical
  • Assists in the training of "junior" personnel
  • Will work closely with various departments at Paragon and aid as needed. This may include support for pre-clinical projects
  • Working closely with various departments and aids as needed Experience & Education:
    • High School Diploma with at least 2 years of relevant experience with warehousing operations
    • Experience with electronic inventory control systems as well as MS Outlook and Excel
    • Documented training (certification) of hazardous materials
    • Mature professional capable of independent work
    • Ability to lift and carry up to 40 lbs. is required Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

Keywords: Paragon Gene Therapy, a unit of Catalent Biologics, Baltimore , Materials Control Associate, Other , Baltimore, Maryland

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