QA Specialist

Description

• Maintain a quality mindset and implement continuous improvement efforts and quality system initiatives to industry requirements.
• Interact with cross-functional groups.
• Responsible for product release.
• Ensure approved quality systems are established and maintained.
• Proactively and continuously improve internal processes and products with quality mindset.
• Report on FDA and regulatory compliance inspections.
• Assist with developing remediation efforts and FDA response when necessary.
• Perform internal compliance, surveillance, and focused audits.
• Develop and maintain audit plan and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions, and prepare final report.
• Perform vendor and supplier quality audits to assure quality of incoming materials and services as necessary.
• Maintain and/or monitor compliance tracking systems and archive records, eg document control, deviation reporting, calibration, records retention, records destruct, etc.
• Understand and follow GMP/GLP/GCP regulations.
• Support the release of finished goods documentation including technical review of batch records, labeling, COA, reprocessing instructions, and lot deviations.
• Assist in the development or edit of new/revised standard operating procedures, forms, flow diagrams, specifications, etc.
• Provide regulatory affairs compliance support and review on regulatory submissions, approvals, product labeling, registrations and other projects.
• Perform technical reviews and approve validation documents, design review, engineering reviews, IQ/OQ/PQ, quality support reports, protocols, final reports, and miscellaneous project documentation.
• Provide compliance and regulatory guidance for existing process, new products and processes, design review, construction and installation, and implementation.

• Bachelor's Degree in a scientific field.
• Minimum of 5 years scientific field preferably in a FDA regulated industry.
• Knowledge of Good Manufacturing Practices, Laboratory Practices and Clinical Practices desired.
• Requires approximately 20% domestic travel and occasional international travel.
• Experience in Canadian, EMEA or Latin American regulated regions desired.
• Advanced MS Excel, Outlook and PowerPoint skills desired.
• CQA Certification desired.
• Must possess strong verbal and written communication skills.
• Ability to work independently required.

SKILLS
MS Excel, MS Outlook, MS PowerPoint, Good Manufacturing Practices (GMP), FDA Regulations, Good Labor Practices (GLP), Good Clinical Practices (GCP)

Synectics is an Equal Opportunity Employer.