Document Control Specialist - Biotech/Biopharmaceuticals

US-MD-Columbia
Job ID
2017-1217
# Openings
1

Primary Purpose of Position

 

The primary purpose of this position is to work within the Quality Assurance department in several key roles relating to document control functions. This position is critical in ensuring compliance with 21 CFR 210, 211, and 1271.

Principal Responsibilities

Responsibilities include, but are not limited to:

  • Generation, review, and issuance of Batch Production Records for use in production of tissue products.
  • Generation and inspection of complex product labeling for all tissue products in production, including ability to identify label and documentation errors.
  • Document performance of each step in accordance with applicable documentation procedures.
  • Maintenance of accurate records and logs in accordance with issuance procedures.
  • Communication and scheduling with the operations department to coordinate receipt of label printing materials and drop off of inspected labels after printing.
  • Scanning, filing, and archival of quality documents to support the quality program operation.

Qualifications

Required:

  • S. or B.A. in Biology or related field preferred and/or equivalent pharmaceutical / biotechnology / tissue bank experience.
  • Ability to work independently in fast-paced environment with minimal supervision.
  • Ability to maintain focus 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.
  • A basic understanding of Good Manufacturing or Tissue Practices (GMP, GTP) and Quality Systems.

Preferred:

  • 1-2 years experience in pharmaceutical or biotech/biopharmaceuticals.

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed