POSITION SUMMARY: The Senior Technician 2, Quality Control will provide an independent review of materials and documentation, supplied by both internal manufacturing and external suppliers, to determine material acceptability. This role will will also assist Quality Engineers with data gathering/ analysis and QMS maintenance.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Perform lot release testing, record data on data sheets and able to summarize, analyze, and perform basic statistical analysis on results when required.

• Perform receiving inspection activities on incoming materials which can include: confirming specifications, performing visual examination and taking variable measurements, and rejecting and returning unacceptable materials.

• Provide independent, secondary review of fellow Technician’s work.

• Assemble sample product as needed for testing purposes. • Document inspection results by completing reports, logs, and inputting data into databases.

• Monitor incoming product quality and report observations upward to Quality Engineering and/or Quality Management.

• Maintain measurement equipment in an operable state by following setup procedure and monitoring calibration status.

• Generate NCR/Deviation Reports.

• Participate in Quality System Improvements through the CAPA process as a contributor.

• Work inside a laboratory environment. Ensure cleanliness of QC areas and properly handle materials.

• Think critically and proactively suggest activities for continuous improvement as opportunities arise during the course of daily work. Propose procedure modifications as appropriate and submit for approval.

• Collaborate with engineers on developing new and modifying existing lab procedures/methods for inspecting and evaluating product.

• Conduct training exercises commensurate with area(s) of functional expertise. • Support internal and external audit activities as assigned by manager.

• Support Internal Manufacturing activities.

• Comply with all applicable company policies and procedures and maintain current training on these records.

• Other activities as assigned by departmental management.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• 4-6 years of experience working in a quality control role with ISO and GMP systems and requirements (an equivalent combination of education and experience may be considered).

• Problem-solver with the ability to exercise sound judgment under challenging circumstances.

• Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.

• Ability to interface with technical services, R&D, manufacturing, and regulatory affairs to accomplish required tasks.

• Ability to communicate with co-workers and all levels of management in a professional manner.

• Familiarity with Microsoft Excel and Minitab and/or other spreadsheet/database software for compilation/trending of data.

• Knowledge of GXP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance

• Possess strong character with self-confidence and integrity necessary to ensure that the patient safety and customer satisfaction are always of utmost importance.

• Strong background in a manufacturing and operations environment

• Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.

• Ability to interface with internal customers at all levels and 3rd-party partners.

ENVIRONMENTAL CONDITIONS:

Physical Requirements: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. Environmental health and safety requirements also apply. Light mechanical duties: intermittent stress due to changing priorities and a variety of tasks that need to be completed in a timely manner. The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.