
Quality Assurance Specialist
hace 1 día
**Job Summary:**
Labchems Corp. seeks a highly skilled Quality Assurance Specialist to support our facilities and construction projects in Collagen areas.
The ideal candidate will be part of the Core Team, participating in meetings and reviewing/approving all documentation required for project success.
This role involves developing technical documentation, including Validation Protocols, Technical/Investigation Reports, SOPs, Validation Plans, and Change Controls.
A fundamental understanding of quality systems and their development, implementation, and maintenance according to domestic and international standards is essential.
Experience with audit processes, including planning, preparation, execution, reporting results, and follow-up is also required.
In addition, this role involves developing and implementing quality programs, tracking, analyzing, and reporting data, as well as problem-solving and product/process quality assurance.
**Requirements:**
- Bachelor's degree in Chemical, Biomedical, Mechanical, or Industrial Engineering
- Minimum 5-7 years' experience in a FDA-regulated environment
- ASQ Certified Quality Engineer and/or Quality Auditor certification preferred
**Nice to Have:**
- Experience with biomaterials or Lyophilization
- Knowledge of Quality System Regulation, ISO, Design Control, and Process Validation
What We Offer:
A temporary contract for one year with competitive compensation and benefits package.
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