Summary:

• The Quality Control Technician ensures products meet applicable quality standards prior to being released.

Job Details
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:
Minimum requirements for this position are:

• High School education or GED equivalent.
• Technical Prefer three (3) to seven (7) years of experience in either Quality Control/Quality Assurance functions within the device, food or cosmetic industry.
• Systems Thorough knowledge of SAP and CORAL
• Regulatory Experience working in a GMP regulated environment preferred.
• Aseptic 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.

Principal Accountabilities:
Percent indicated is the average time spent on a task and will vary depending on the workflow.

Time Task # Description of Task:

• Samples, inspects and releases components and chemicals per pre-established procedures using both visual and metrology techniques to assure conformance to procedures and cGMP's. The inspector position is required to pull chemical samples for Microbiology and Chemistry in a controlled environment. Releases components and chemicals using SAP to direct these components to the appropriate stage to assure the immediate access to these materials for production's use and to notify material planning of rejects.
• Inspects finished product samples per pre-established procedures using both visual and metrology techniques to assure conformance to procedures and cGMP's. Maintains physical stability program. Supports Production during the manufacturing process when needed. Responsible for performing line clearance and set-up verification in support of Production.
• Maintains files and documentation of inspection reports and logbooks to assure traceability of raw materials, components, and finished product. Maintains component retain samples. Pulls product retain samples. Evaluates conditional situations within the department to incorporate continuous improvement and assist with and/or lead the department with projects (Green Belt). Create, revise, and review procedures when needed.
• Provides input and assists in preparation of standard operation procedures. Provides input and assists in problem solving and analysis with production manufacturing, deviation write-ups, and continuous improvement
• Helps to develop team approach to department knowledge of and adherence to departmental and company safety policies. Follows all cGMP and safety requirements. Assists in training personnel where applicable with Quality as well as Production.

Job Types: Full-time, Contract

Salary: $18.00 - $20.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location

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