Quality Technician
Position summary:
The primary purpose of this position is to monitor the in-process quality controls of products manufactured on the production floor and to ensure all production activities are compliant in respect to FDA, cGMPs, and SOPs. This position is responsible for performing inspections, testing, documentation, and supporting continuous improvement initiatives in a regulated manufacturing environment.
Essential functions and responsibilities:
- Perform routine in-process and final product inspections to ensure compliance with GMP and company quality standards
- Conduct sampling, testing, and documentation of raw materials, components, and finished goods
- Issues labels to the production line
- Performs line clearance activities and subsequently releases the line to begin production activities.
- Maintain accurate and complete records of all quality activities, including deviations and non-conformances
- Performs balance weight verifications and challenges metal detection instrumentation.
- Assist with root cause investigations and implementation of corrective and preventive actions (CAPAs)
- Ensures products are free of defect through in-process quality control monitoring
- Ensure proper calibration and maintenance of inspection and test equipment
- Support validation activities and change control processes
- Participate in internal audits and support regulatory inspections
- Collaborate with production and QA teams to resolve quality-related issues
- Ability to work in a fast-paced, regulated environment
- Perform additional duties as needed.
Success factors/job competencies:
- Follow Instructions
- Collaboration/Team Player
- Customer Service Orientation
- Sense of Urgency
- Attention to Detail
- Coaching/Teaching
- Quality Orientation
- Safety Orientation
Physical demands and work environment:
- Must be able to walk, stand, sit, see, hear, and speak for extended periods of time.
- Ability to read and comprehend data.
- Ability to lift up to 30 pounds.
- Ability to change in and out of scrubs in a timely manner (within 5 minutes).
- Ability to lift hands and arms over head to apply proper PPE and moving materials up to 30 pounds.
- Work involves exposure to known allergens including but not limited to peanuts.
-
Work Days and Shifts:
- Position works primarily Monday through Friday with varying shifts. May require occasional weekend work
- . Experience and Education
- Must periodically pass random drug screening.
- Level 1 : High school diploma or equivalent work experience
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