Summary of Position:
The Quality Assurance Specialist is responsible for quality support for all activities related to the manufacture and testing of products through all phases of the clinical lifecycle. The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical, quality systems and GMP/GLP requirements. The essential duties will be to support product disposition, clinical trial material disposition, product testing, investigations, change control, risk assessments and quality systems. The candidate will help to create a quality-oriented culture throughout the organization.
- Manage lot review activities for clinical material/products to ensure disposition timelines are met.
- Review and manage deviations from contractors related to manufacturing and testing.
- Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP/GLP expectations.
- Communicate and resolve discrepancies with CMOs/CTLs.
- Compile and manage lot files.
- Assist in the preparation, execution, report and follow-up of internal and external audits.
- Participate in quality system improvements.
- Monitor project progress to ensure efficient and effective communication on project status and issues.
- Author, review and revise site SOPs to ensure compliance with GDPs, regulatory requirements and corporate standards.
- Perform other duties as assigned by Quality Management
Job Requirements (Essential knowledge, skills and attributes):
- Bachelor of Science degree or higher in a scientific discipline is required.
- A minimum of 5 (five) years of GMP quality assurance experience in biopharmaceutical industry is required.
- Demonstrate a solid understanding of biologics manufacturing – process, analytical operations, quality systems and regulations.
- Direct experience with document management, SOP development, batch record review and product disposition are required.
- Experience in GMP/GLP record review, investigations, change control, validation and risk assessment.
- Ability to build strong collaborative relationships with partners in and outside of the organization.
- Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
- Ability to manage competing priorities and timelines in a fast-paced, rapid-growth environment.
- Excellent problem-solver with the ability to work independently.
- Experience with providing direct oversight and support to clinical material manufacturing operations is highly preferred.
- Experience performing deviation investigations including CAPA planning and management is highly preferred.
- Excellent attention to detail.
- Proficient use of MS PowerPoint, Excel and Word.
- Occasional travel up to 5-10% of time.
- Experience performing Quality audits, a plus.