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Quality Assurance Technician

3 months ago

Glendale Heights, United States Medefil, Inc. Full time

**Summary**: The Quality Assurance Technician performs daily QA activities, provides support and oversight to the Production facility.

**Duties and responsibilities associated with the position and detail the activities to be performed**:

- Responsible for sampling and inspection of components, labels, and in-process and finished products.
- Perform incoming material sampling, testing, release, and documentation.
- Communicate testing results and disposition to stakeholders as required.
- Issuance of label material.
- Production line clearance.
- Visual inspection of finished product during filling/packaging process.
- Perform label inventory
- Provides help to QA in the implementation and improvement of the Quality Management System as it relates to 21 CFR Part 11, 210, 211 and 820.
- Help in batch records review and release activities.
- Maintain accurate records per cGMP’s and applicable international standards.
- Comply with established Quality Management System procedures and company policies.
- Support all internal, customer, and regulatory (FDA and ISO) audits.
- Perform other duties as assigned.

**Education Minimum / Recommended**:

- High School Diploma minimum
- Associate degree, or Bachelor degree in Science Field is preferred

**Work Experience Required**:

- Minimum of 1 Year in Manufacturing environment
- GMP Pharmaceutical or Medical Device industry preferred.

**Specialized Knowledge (Regulatory, Technical Certification, etc.)**:

- Not Applicable

**Skills (Reading, Writing, Verbal Communication, Mathematics, Computer, etc.)**:

- Good organizational, communication, teamwork, and interpersonal skills
- Must be able to work in 2nd shift/evening shifts, and if needed work weekends
- Ability to work independently and have good time management skills
- Good verbal and writing skills
- Excellent attention to detail
- Basic Computer Skills.
- Ability to lift 50 lbs.

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance

Schedule:

- Monday to Friday

**Education**:

- Bachelor's (required)

**Experience**:

- Quality assurance: 2 years (preferred)
- Pharmaceutical: 2 years (preferred)

Work Location: Multiple locations