The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.
Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position builds upon the skills and responsibilities of a Quality Technician and requires an increased level of self-direction and motivation. This position regularly interacts and collaborates with other departments within the company.
- Perform all work in compliance with company policy and within the guidelines of its Quality System.
- Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
- May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
- Other Duties
- Effective written and verbal communication skills
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- General computer operation
- Attention to detail is fundamental to this position.
- Ability to accurately follow written and verbal instructions.
- Organization skills as needed to maintain paperwork and task schedule.
- Proficiency in internet navigation
- Basic math proficiency
- Enter data into the CAL/PM software
- Scan calibration certificates into the Cal/PM software
- Perform Level 1 Calibrations (Pipette, Pressure, Calipers)
- Perform second person verification of calibration
- Escort suppliers into restricted areas to perform on-site calibration
- Review and approve calibration and preventative maintenance forms
- Perform contamination swabbing
- Schedule vendor calibrations
- Create NCR’s for out of calibration events
- Respond to "out of tolerance" events
- Respond to temperature monitoring alarms
- Alert manager of equipment outside of its calibrated state
- Alert manager of incomplete and inaccurate documents
- Review and determine compliance of equipment within calibration requirements.
- Review quality documents for completeness and accuracy
- In-Process QC confirmation of new equipment and input of new items into CAL/PM software
- Perform Level 2 Calibrations (Temperature, Freeze Dryer Temp, Scales, and Centrifuges)
- Perform second user calibrations on pipettes
- Under supervision can assist with daily sweeps of manufacturing areas to ensure cGMP
- Perform Level 3 Calibrations (Freeze Dryer Pressure, Encoders, Torque, Multivac)
- Review and approve calibration and preventative maintenance forms for production equipment.
22. Determine corrective actions for out of temperature events
23. Determine corrective actions for out of calibration events
Physical Requirements:
- Be able to utilize various personal protective equipment (PPE), including respirators
- Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be up to 50 lbs.
Training & Education Requirements:
1. High school diploma or equivalent is required.
2. Associate degree (or higher) in a life science or engineering discipline is preferred.
3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
Experience:
1. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
2. Minimum additional 1-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of this experience.
Skills & Qualifications:
ASQ Certified Calibration Technician certification is a preferred
