Job Description
Job Description
Salary : $80,000.00 - $85,000.00 per year
Purpose :
The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards.
Duties & Responsibilities :
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP / CGTP, and other organizations policies and procedures.
- Author, revise, and maintain procedures / controlled documents according to FDA, AATB, and other applicable regulations.
- Manage processes and efficiency in department to support organizational strategic objectives.
- Establish, evaluate, report, and provide improvements (where appropriate) for quality
- Manage and oversee review of HCT / P donor records for final product release in accordance with standard operating procedures and regulatory / accrediting agency requirements.
- Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
- Assist with training of processes and corrective actions relating to
- Support development of validation / qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
- Review and approve qualification / validation / verification protocols, execution data, and summary
- Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
- Maintain professional working relationships with customers, partners, and
- Manage direct reports and monitor individual
- Maintain records in accordance with standard operating
- Attend / participate in offsite business meetings / conferences.
- Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
- Perform other related duties as assigned.
Skills & Abilities :
- Leadership & Management skills
- Attention to detail
- Organized
- Verbal / Written Communication skills
- Analytical Thinking skills
- Technical Writing skills
- Multi-tasking skills
Education & Experience :
- Bachelor’s degree in a biological science or related field required.
- At least 5 years of experience in quality in an FDA regulated environment for HCT / Ps and / or medical devices (or related field), with progressive management responsibility / experience preferred.
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