The Quality Control Technician ensures products meet applicable quality standards prior to being released.
This position is responsible for the following:
- Performing component and final product inspection, physical stability program, and maintaining documentation of inspection reports to support component, raw material and finished product release.
- Maintaining and tracking all incoming and outgoing FQA product with traceability through FQA Delivery logbooks and destruction of FQA Sample logbook.
- Destroying all FQA samples through approved methods.
- Maintaining and updating LMS training daily.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Thorough knowledge of SAP and CORAL
Experience working in a GMP regulated environment preferred.
Experience working in an Aseptic Production environment preferred.
Essential Knowledge, Skills & Abilities:
- Able to lift up to 35 pounds (women), 40 pounds (men).
- Must exhibit good written and verbal communication skills.
- The ability to read, write and comprehend English and follow instructions in order to perform the responsibilities described above.
- Ability to work under pressure and with general direction to meet deadlines and concentrate on details and following instructions.
- Good problem-solving skills and be detailed oriented.
Significant Work Activities: N/A
Job Type: Experienced