Quality Assurance Inspector
5800 Newton Drive Carlsbad, CA 92008
Performs sampling of raw materials, intermediates and finished goods. Inspects, defects and dispositions, according to specific product quality specifications, finished goods and documents results in manufacturing batch record. Oversees manufacturing personnel and procedures adherence to departmental and company standard operating procedures and GMP guidelines. Performs routine facility environmental testing as well as basic laboratory and manufacturing equipment calibration and assorted physical and chemical testing relating to the manufacture and quality of dietary supplements.
Responsibilities include but not limited to:
- Performs sampling of raw materials, intermediates, and finished goods for testing. Enters all required documentation in the sampling specification report, mfg. batch record and inventory card before and after testing and approval.
- Inspects, defects and dispositions resulting finished goods according to specific product quality specifications. Documents any quality related process and product findings in the mfg. batch record and, if required, prepares ancillary reports.
- Provides area clearances to manufacturing personnel prior to dispensing, blending/compounding, encapsulation and bulk packaging operations.
- Oversees adherence or procedures and personnel to established standard operating procedures and GMP guidelines. Conducts routine manufacturing internal audits, documents and reports non- compliance issues to QA management.
- Responsible for warehouse and production areas environmental monitoring including temperature and humidity control, particle count and in-process swab sampling for microbiological testing.
- Performs basic laboratory instrumentation and production equipment calibrations. Performs daily checks to ensure that all manufacturing equipment is used within preventive maintenance and calibration periods.
- Reports any safety hazards to Supervisor or Maintenance.
- Performs any other duties assigned by Supervisor or Manager.
- Able to lift, bend climb and reach. (Forklift training, preferred)
- Analytical, computer and mathematical skills. Minimum of a HS diploma required.
- Good communication skills, including ability to read and write in English. (Bi-lingual language skills in Spanish, helpful but not required).
- Previous QA experience preferred
- Flexibility in work hours preferred.
Required knowledge and skills:
- At least high school diploma and experience in pharmaceuticals industry is preferable.
- Experience Required: 2+ years