Quality Assurance Specialist

About the company

Gator Bio

Biotechnology · 51 to 200 employees

What you'll do

• Maintain the established Quality Management System (QMS) in accordance with applicable standards and company procedures.
• Promote awareness and compliance with quality requirements across the organization.
• Manage controlled documents, quality records, forms, and other quality-related documentation.
• Manage document and change control activities, including document revisions, approvals, implementation, and periodic reviews.
• Manage the quality training program, including the training matrix, training assignments, and completion tracking.
• Follow up on overdue training and maintain training records.
• Coordinate training related to quality system procedures and requirements.
• Manage the equipment calibration and maintenance program.
• Monitor calibration and maintenance schedules and due dates.
• Maintain calibration and maintenance records and follow up to ensure activities are completed on time.
• Support the evaluation and documentation of out-of-calibration or out-of-service equipment.
• Perform product and/or batch release by reviewing required quality records and documentation.
• Work with Manufacturing and QC to ensure quality requirements are completed prior to release.
• Support the investigation and resolution of quality issues that may affect product quality or release.
• Support nonconformance (NCR), CAPA, complaint handling, and audit activities as needed.
• Perform other QA and quality-related activities as assigned.
• Maintain appropriate records and documentation for assigned quality activities.
• Work closely with Manufacturing, R&D, QC, Operations, and other functions to support quality activities and resolve quality issues.
• Provide timely QA support for projects and operational activities.

What you need

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, Engineering, or a related scientific or technical field.
• 2+ years of experience in Quality Assurance in a life science, biotechnology, diagnostics, medical device, or other regulated environment.
• Working knowledge of Quality Management Systems and applicable quality standards.
• Experience with quality documentation and records.
• Attention to detail and organizational skills.
• Ability to manage multiple priorities and follow through on assigned activities.
• Written and verbal communication skills.
• Ability to work effectively with cross-functional teams.
• Experience working in an ISO 13485, FDA-regulated, or other regulated life science environment.
• Experience performing product or batch release.
• Experience with equipment calibration and maintenance programs.
• Experience with electronic QMS or other quality management systems.
• Familiarity with GxP requirements.
• This role will require lengthy periods of standing and sitting.
• The employee will be required to use hands for computer work.
• Health screening: Not required

Key skills

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