RESEARCH & DEVELOPMENT QUALITY SPECIALIST (OKLAHOMA CITY, OK)
ADVANCE YOUR CAREER WHILE SAVING LIVES
Location: Oklahoma City, OK
Salary: Competitive salary based on education and/or experience plus $500 bonus after 6 months and $1,000 bonus after 1 year!
Benefits: Health, dental, vision, life insurance, long term disability, 401(k), paid-time off, $5,000 annual tuition reimbursement, holiday pay, etc.
Days: Monday through Friday
Hours: 8:00 a.m. to 5:00 p.m.
Position:
Our Blood Institute is looking for a Research & Development Quality Specialist in Oklahoma City who will provides support in the review of certificates of analysis, deviation and event management, and clinical trials. In addition, the position reviews research and development processes to ensure Good Manufacturing Practices and Good Documentation Practices are followed. The position may also assist with external customer audits.
Qualifications:
- Minimum of a bachelor's degree in chemical, biological or clinical laboratory science from an accredited institution
- 2 years of relevant experience in a quality assurance role
- GMP experience preferred
- Quality Systems experience preferred
- MLS(ASCP) or MLT(ASCP) preferred
- Basic understanding and knowledge of GMPs
- Ability to work independently
- Must be self-motivated and detail oriented
- Strong computer skills
- Excellent communication skills, both written and verbal
- Ability to define problems, collect data, establish facts and draw valid conclusions
- Strong critical thinking and problem-solving skills
- Ability to multi-task
Primary Responsibilities:
- Review certificates of analysis for required information and accuracy
- Report and assist in the investigation, reporting, and resolution of deviations and customer complaints
- Participate in clinical trial oversight for OBI studies
- Manage clinical trial tasks, IRB queries, and required reporting
- Facilitate and participate in process improvement initiatives between research and other departments
- Training coordinator for Research & Development
- Review GMP charts to verify documentation meets regulatory and quality standards
- Author and edit SOPs to ensure alignment with FDA 21 CFR 1271, internal quality requirements, and client specifications
- Review and analyze quality data to assess process compliance and identify trends and present to internal stakeholders