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Biotechnology Quality Assurance Specialist

Post Date:Dec 28, 2017Type:Full-Time
Start Date:12/28/2017Salary:$50,000.00
Location:US-MD-Gaithersburg Job Reference:63832
**Quality Assurance Experience Specifically Within Documentation or Batch Record Review in a Biotech Setting**

Job Description:

Medix is looking for a Quality Assurance Assocaite specifically focused on document review! This person would be joining a fast-paced team that is producing high amounts of documentation due to their busy production schedule! This is a gene therapy company that needs someone who has familiarity with GMP and Good Documentation Practices (GDP) to come in and help with the surplus of documentation.

Daily responsibilities are:

  • Support the Quality Assurance systems by means of guaranteeing GMP compliance for the relevant operations being carried out within and for the company
  • Responsible for authoring, reviewing and revising relevant documentation, performing quality reviews, conducting review of batch production records, providing mechanism for isolating and quarantining, conducting investigations, and assisting in hosting audits


  • BS in Life Science 2+ years of GMP is required
  • QA experience required
  • Experience reading and reviewing SOPs and other documentation
  • Experience writing SOPs or documentation as it relates to manufacturing
  • Gene Therapy experience preferred

Soft Skill/Attribute Requirements:

  • Attention to detail
  • Excellent communication skills
  • Ability to multitask


  • Duration: Contract position that is open-ended (no definitive end date)
  • Hours: 8am-5pm; OT is given if desired
  • Location: Gaithersburg, MD

Contact Information
Name: Medix

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