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ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Quality Control Technician II will be responsible for performing quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and procedures purchased components, manufactured sub-assemblies and final product. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing.

• Responsible for performing Analytical testing such as TOC, Conductivity, Osmometry and pH testing.

• Perform mechanical testing, DSC (Differential scanning calorimeter) and DBT (Burst testing).

• Inspection and testing of raw materials, in-process, and final product testing.

• Monitors equipment and instrumentation used daily to ensure proper operation and calibration.

• Assists in the writing and updating of analytical test procedures, protocol, logbooks, and checklists.

• Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.

• Develops and revises SOPs and trains appropriate new hires.

• Maintains a working inventory of all components and archived materials and solutions as needed.

• Assist as needed in test method validation, investigation studies or other product development studies.

• Provides database support, generates reports, and analyzes the data as needed.

• Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).

• Assist in preparing for and participating in FDA audits, customer audits, etc.

• All other duties as assigned.

DESIRED MINIMUM QUALIFICATIONS:

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s Degree in the biological or chemical sciences or equivalent with related work experience is required.

• A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.

• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.

• Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

• Experience with performing Instron, DSC and DBT testing preferred. Working knowledge of standard laboratory practices and safety.

• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.

• Experience working in ISO Class 7 cleanrooms preferred.

• Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

TOOLS AND EQUIPMENT USED:

Working knowledge and understanding of instruments including pH, Conductivity, Total Organic Carbon Water, Osmometry, Instron, Deferential Scanning Calorimeter, Identification of Raw Materials, and the visual inspection of raw material in-process and final product samples.

PHYSICAL REQUIREMENTS:

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of this position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must speak and write in English.  The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.

ADVERSE WORKING CONDITIONS:

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.