QA Specialist I

TITLE:  QA Specialist I  DEPARTMENT: Quality Assurance

 

REPORTS TO:  QA Lab Manager

 

EDUCATION/EXPERIENCE:AA Sciences/Engineering or equivalent and 0-2 years experience in a medical device or

pharmaceutical company. Experience in a FDA/ISO regulated industry preferred.

 

SKILLS:

 

1. Basic knowledge of algebra, statistics, weights/measures and the metric system.

2. Basic working knowledge of Microsoft Word, Excel, and Outlook.

3. Ability to use hand-held metrology instruments (calipers, height gauges, pin gauges, micrometer, etc).

4. Ability to communicate thoughts and ideas effectively in English, both orally and in writing.

 

ESSENTIAL FUNCTIONS:

 

1. Follow detailed Quality Assurance procedures.

2.  Follow basic Quality Assurance protocols and data gathering steps.

3.  Perform metric inspections of raw materials for HCD product lines.

4.  Identify non-conforming materials and protocol/procedural errors.

5.  Coordinate with Team Leader in determining work assignments to meet production timelines.

6.  Perform inspection of approved spools.

7.  Assist with customer complaint testing as needed.

8.  Perform basic QA document changes and revisions (DCO’s).

9.  Perform inspection of finished products/packaged goods.

10.  Maintain laboratory inventory and order supplies as needed.

11.  Perform rudimentary equipment (CLA Luminometer) troubleshooting.

12.  Regularly clean laboratory and maintain a neat and organized work area.

13.  Support QA Laboratory as needed.

14.  Perform additional duties as necessary.

 

ADDITIONAL NECESSITIES:

 

1. Trained in cGMP’s and current ISO 9000/13485 regulations.

2. Ability to succeed within a team based environment.

3. Self-motivated and self-initiating.

4. Demonstrate a positive and professional demeanor throughout QA and all HCD departments.

 

PHYSICAL DEMANDS: 

 

Position requires the ability to sit, stand, walk, talk and hear.  Specific vision abilities include close vision, working with a computer monitor for up to 4 hours and the ability to adjust focus.  Physical strength demands the ability to lift up to 30 pounds and perform work in cold rooms for up to 20 minutes.

 

WORK ENVIRONMENT: 

 

While performing the duties of this job, the employee will work with blood-borne pathogens and hazardous chemicals.  Where applicable, employee must wear personal protective equipment including: laboratory coat, glove, safety goggles/face shield and hairnets