POSITION PURPOSE:
Responsible for developing and implementing quality assurance policies, conducting tests and inspections, identifying production process, or product issues, and presenting solutions.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:

• Coordinate QA inspections of incoming materials, arranging for inside or outside testing as required. (This does not include routine receiving inspections performed by Shipping/Receiving personnel.)
• Inspect finished product and manufacturing records to verify conformance to specifications and regulatory requirements as part of release to distribution activities.
• Coordinate outside testing of production batches as required.
• Create records when non-conformances are apparent during inspection.
• Receipt all production batch tickets in RCC’s enterprise resource planning (ERP) system.
• Ensure non-conformances are dispositioned timely and properly through the MRB process in accordance with policies.
• Provide regular updates and recommend potential improvements to manager regarding the proper implementation of procedures, work instructions and policies on the production floor.
• Support the Quality Assurance department in customer, internal and supplier audits as assigned by manager.
• Support the Quality Assurance department in the investigation and resolution of customer complaints as assigned by Technical Service and/or manager.
• Conduct relevant trainings as appropriate.
• Management of retained samples.
• Review, update and develop work instructions, procedures and forms relevant to the quality management system as assigned.
• Consistently meets/exceeds standards assigned within Functional Training Document (FTD) program.
• Any other tasks deemed necessary.
• Commitment to the organizations values; High Standards, Bias for Action, Teamwork, CustomerObsession, Trust, Accountability, Innovation and Growth & Learning.

REQUIRED SKILLS:

• Good communication
• Critical thinking and problem-solving
• Time management
• Analytical
• Organizational skills
• Patience and determination
• Scientific and numerical skills

EDUCATION AND EXPERIENCE:

• High school diploma/GED required, two-year degree preferred.
• Certificate in quality assurance is a plus.
• Previous experience in quality assurance or a similar field.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Solid knowledge of relevant regulatory standards.
• Good communication skills, both verbal and written.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Knowledge of ISO 17034 standard is a plus.
• Strong organizational skills, meet deadlines, work independently and with the team with strong follow through, strong communication skills, both written and verbal and accuracy and attention to detail.

WORK ENVIRONMENT:
The physical environment may require the employee to work both inside and outside in heat/cold, wet/humid, and dry/arid conditions. This position may be working in the warehouse under various indoor environmental conditions, including supplemental heating in the winter months and without air-conditioning in the summer months. May be requested to work overtime and weekends. The position may occasionally be exposed to ruptured, leaking packages, some of which may contain Hazardous Materials. Where appropriate, proper safety equipment should be utilized and/or appropriate personnel notified. Frequently required to use personal protective equipment to prevent exposure to hazardous materials and chemicals. This job may require lifting of up to 50 pounds occasionally.