- Quality Assurance
- Manufacturing Experience
The primary purpose of this position is to review production control records and all associated documentation for manufactured tissue products and to assist in reviewing, inspecting, and disposition of incoming raw materials, returned goods, and processing of rejected product.
Review of supplemental documentation associated with tissue product manufacturing performed at Osiris, including label records, environmental monitoring records, cleaning records, quality control testing records, autoclave records, and donor eligibility records.
Performance of autoclaved material disposition prior to use in manufacturing.
Review and evaluation of tissue product production records for disposition.
Review and evaluation of production record documentation from contract manufacturing organizations.
Maintenance and reporting of the production record review metrics for both Osiris and contract manufactured products.
Scanning, filing, and archival of QA related documents.
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 maintain focus and prioritize appropriately 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.
B.S .or B.A. in Life Sciences or related science based field.
Required: 2 years of experience in a regulated biotechnology or pharmaceutical environment (GMP, GTP).
Required: 1 – 2 years of experience performing batch record review or manufacturing using batch records at a regulated biotechnology or pharmaceutical company.
Preferred: 1 – 2 years of experience in Quality Assurance performing batch record review and disposition at a regulated biotechnology or pharmaceutical company.
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.