What are the responsibilities and job description for the Quality Assurance Technician position at TCI BIOTECH USA?
Job Details
Description
General Description:
The Quality Assurance Associate will inspect, test, review, investigate, verify, and streamline the quality assurance/quality control processes in Quality, Production, Manufacturing, Packaging, and other quality-related areas to provide quality support and coverage in Production, ensuring all products and materials are meeting specifications, compliance and regulatory standards. The Quality Assurance Associate will also provide documental support in performing quality checks and reviews on batch records and creating, revising, and training SOPs, ensuring all quality inspections are completed promptly and compliant. This position will record, handle, and report any quality-related issues in Production to the Quality Assurance Supervisor.
Location: (Onsite) 737 E 1180 S, American Fork, UT 84003
Schedule: Monday - Friday, 8 AM - 5 PM. This will rotate shifts every 3 months, working as Incoming Quality, Line Quality, and Documentation Quality.
Responsibilities:
- Manage and maintain all controlled documents
- Update and control procedure documents and forms
- Ensure all documents meet set standards in terms of quality and compliance with FDA Regulations.
- Coordinate all activities related to the document control procedure, including the distribution of documents and ensuring access.
- Implement and maintain document control processes and procedures
- Develop and maintain the comprehensive filing system and computer database for all documents to be retained
- Manage the flow of documentation within the organization
- Prepare reports and audits to help identify document inconsistencies
- Ensure all documents are up-to-date and accurately reflect current policies and procedures
- Internal audits on documentation on other departments
- Daily GMP Audits
- Daily walk-through Audits
- Releasing of Raw materials and Finished goods
- Line checks
- Monitor temperature
- Identify gaps inefficient process workflow and suggest steps for quality process improvement.
- Collect, prepare, and analyze data for corrective action and process improvement.
- Ensure materials and products meet defined product specifications and standards.
- Document the results of all inspections.
- Review, compile, and analyze information to prepare reports.
- Accept responsibility for your safety and that of others.
- Assist in defining and improving processes as part of a team.
- Investigate quality issues to identify root causes and ensure issues are addressed and resolved.
- Analyze all customer feedback for trends and continuous improvement.
- May be required to lift and transport up to 40 pounds.
- Prepare and present materials/findings both internally and externally.
- Work overtime as needed.
Qualifications
Required Skills:
- Knowledge of FDA regulations is a plus
- Attention to detail, critical thinking, and effective organization skills required
- Strong communication and proficient soft skills
- Ability to multitask, the ability to work in a fast-paced team environment
- 2 Years of experience
- Knowledge with Microsoft
- Problem-solving and process improvement skills
Education:
- High School diploma required
- Associate or BS/BA College degree preferred