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Medix

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
Skills:
**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

Requirements/Qualifications:

  • 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

Logistics:

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




Contact Information
Medix
Name: Medix


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