The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Calibration & Preventive Maintenance, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.
This is an entry-level position. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventive maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. 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
Knowledge, special skills and/or abilities required to perform the job functions (e.g., negotiation, technical writing; statistical evaluation).
1. Effective written and verbal communication skills
2. Proficiency in MS Office tools, including Outlook, Word, and Excel
3. General computer operation
4. Attention to detail is fundamental to this position.
5. Ability to accurately follow written and verbal instructions.
6. Organization skills as needed to maintain paperwork and task schedule.
7. Proficiency in internet navigation
8. Basic math proficiency
Principal Job Duties and Responsibilities:
- 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
Qualifications
Training and Education:
- High school diploma or equivalent is required
- 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. Experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
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 required to lift up to 50 lbs
