Quality Assurance Specialist
4 days ago
Job Description:
We are seeking a Quality Assurance Specialist to join our team at Aspen Co-Pak LLC. This role encompasses creating and maintaining quality documents, conducting investigations, training, audits, and ensuring compliance with the quality system.
Key Responsibilities:
- Create, update, and maintain master manufacturing records (MMRs), batching and production records
- Create, update, and maintain finished product specifications, raw material specifications, and packaging specifications
- Assist in maintaining SOPs, forms, work instructions, and other quality documents as needed
- Creates deviations and change control records
- Reviews and approves incoming labels based on customer standards or customer approval
- Organize, file, and maintain documents and records as needed
- Assist with supplier approval program
- Inspect, pull samples, and release incoming materials
- Manage environmental monitoring program (pull samples, review, and track results)
- Assist with HACCP and food safety programs
- Participate in ensuring plant-wide pre-requisite programs are instituted and functioning
- Help ensure plant-wide GMP compliance
- Assist in internal auditing program; assess non-compliances and make recommendations for corrective actions to management
- Assist with customer complaints, corrective actions, and CAPAs
- Assist with GMP training
- Assist with review of production records, test result review, and finished product release
- Backup to Quality manager
Requirements:
- Knowledge of Quality Assurance systems and procedures, FDA, Good Manufacturing Practices (GMPs), HACCP, and internal auditing
- Ability to understand and interpret product quality, specifications, and regulatory documents
- Work as a team player
- Ability to communicate effectively and professionally
Benefits:
- Competitive salary: $65,000 - $80,000 per year
- Opportunity for professional growth and development
- Collaborative and dynamic work environment
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