Quality Coordinator
2 weeks ago
SURGENEX® is a privately held biotechnology company. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.
- Execute key quality functions in support of product flow in production, logistics, and distribution.
- Perform document quality and accuracy reviews for: production documentation, shipping logs, inventory logs, equipment logs and cleaning logs.
- Communicate and assure Quality system requirements are effectively established and effectively maintained though verification activities.
- Review and audit processes and procedures to assure compliance
- Responsible for reviewing all donor charts including donor screening documentation, serology reports, sterility reports and culture reports.
- Monitor status of equipment calibration and maintenance
- Compile all applicable records in donor charts for Medical Director review for release of tissue.
- Assist with the establishment and implementation of new or revised policies, as well as management of the Document Control (and change order) system.
- Responsible for conducting audits as SOPM dictates.
- Other duties as assigned.
**Preferred Knowledge and Skills**:
- Strong interpersonal, written and oral communication skills
- Strong organization and time management skills to be able to manage complex work responsibilities
- Knowledge and experience in the medical manufacturing industry, particularly in: Quality assurance (QA) and quality control (QC), AATB accreditation, documentation management, Good manufacturing practices, (cGMP), and internal auditing.
**Preferred Qualifications**:
1+ years of work experience as QA/QC specialist in the Pharmaceutical/Biotechnology or Health related industry.
Shifts
2nd shift: 2pm-11pm
2nd shift: 2pm-11pm (Weekends)
- **Covid-19 vaccination required**
Pay: $43,560.00 - $47,520.00 per year
**Benefits**:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- Weekends as needed
Work setting:
- In-person
**Experience**:
- Quality control: 1 year (preferred)
Work Location: In person
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