Description
Position Summary
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. 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.
Primary Duties
- 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
Supplemental Data
- Minimal domestic travel may be required for training purposes
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
- Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
- Experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.
Knowledge, Skills, and Abilities
- 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.
- Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
- Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).
Proficiently
a. Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.
b. Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.
c. Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records.
d. Physically release work in process for finished goods processing
e. File and archive quality records according to established processes.
f. Prioritize product release to meet department goals
Physical Requirements
1. Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
2. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
3. Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company.
4. Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.