What are the responsibilities and job description for the Quality Assurance Specialist position at K-Max?
Quality Assurance Specialist
GENERAL DESCRIPTION
Quality Assurance Lead aims to ensure that the company’s product meets both customer expectations and government regulatory compliances. Examples of material are, but not limited to, softgels, capsules, tablets of dietary supplements.
ESSENTIAL JOB DUTIES Essential job functions and duties include, but are not limited to, the following:
Organize and maintain both electronic and hard copy raw data.
Ensure that all received materials released for production meet validated requirements and FDA cGMP regulations. Assist in validating incoming materials’ Certificate of Analysis (COA) against the current company specifications.
Perform plant walk-through to verify all procedures are well executed by our employees, if poorly executed, record and report to Department Leader. File Deviation and CAPA report.
Ensure that all finished goods released for sale meet validated requirements, product specification, and FDA cGMP regulations.
Conduct regular audits such as documentation, product traceability, GMP, etc.
Assist in regulatory inspections, third-party audits, and customer on-site audits.
Job Knowledge, Skills & Abilities:
* Proficient knowledge of quality system awareness as they apply to FDA cGMP standrads.
*Effective written and oral communication skills/techniques.
*Possess basic PC skills/usage (Microsoft Office).
*Ability to maintain a professional demeanor, appearance, and conduct at all times.
*Ability to maintain a positive, cooperative work-relationship with employees, peers, management, and customers.
*Adapt effectively to change and handle new job tasks/challenges in a positive manner.
Job Types: Full-time, Contract
Pay: From $20.00 per hour
Benefits:
- 401(k)
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
Education:
- Bachelor's (Preferred)
Experience:
- Manufacturing: 2 years (Preferred)
Language:
- Mandarin Preferred (Preferred)
Shift availability:
- Day Shift (Preferred)
Work Location: One location