Quality Control Technician

POSITION SUMMARY:

 Perform various release criteria tests, using defined guidelines and Standard Operating Procedures (SOP’s), to determine if materials/goods are acceptable for release.  Compare test results for compliance with company and regulatory requirements, record results, and notify management of out-of-specification tests and trends.  Inspect and ensure supplies received in the warehouse that are used in the production and/or packaging of tissue products and finished goods meet quality standards. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform well –defined, standardized tests on donor culture samples, processing supplies and finished goods before they can be released for use, such as:
  • Microbiological identification of bacterial and fungal growth in/on both liquid and plate media; subculturing and identification of microorganisms to determine acceptability based on sample type
  • Environmental monitoring of controlled environment areas (CEA), testing all surfaces and areas for the presence of organisms to ensure required sterility standards are met
  • Water tests to monitor levels of bioburden, total organic carbon, and conductivity from all water ports used in the manufacture/sterilization of tissue products and equipment
  • Residual moisture tests on tissue product to ensure moisture levels in products are at acceptable levels
  • For testing not conducted in-house, send samples to approved contract labs and review results for acceptability
• Conduct physical inspections of raw materials (e.g. gowns, gloves, instruments, etc.) and finished goods (e.g. packaging, labels, marketing materials, etc.) received in the warehouse, per guidelines outlined in SOP’s or material specifications
• Compare findings of test results to established guidelines; identify reasons for failure and retest as permitted; initiate investigation for any failed test (i.e. out-of-specification result)
• Assist in investigations, corrective actions/preventive actions (CAPA’s), document changes, trending, etc. by providing requested information and implementing defined, corrective measures
• Document and record results of tests in internal database
• Perform preventive maintenance and cleanings on equipment (e.g. incubators, refrigerators, carbon analyzers, etc.) used to perform quality control tests and/or in the manufacture of tissue products, as scheduled

PROBLEM SOLVING:

• Effectively identifies problems as they occur and takes appropriate steps to solve them in situations where the problem is not difficult or complex
• Refers complex, unusual problems to supervisor or manager

DECISION MAKING/SCOPE OF AUTHORITY:

• Under general supervision, exercises some judgement in accordance with well-defined policies, procedures, techniques
• Work typically involves regular review of output by a senior coworker or supervisor

SPAN OF CONTROL/COMPLEXITY: 

• Fully functioning support role having greater responsibility to perform all (or most) of the standard work within the function; moderate impact to the department

EDUCATION/EXPERIENCE:

• BS/BA degree, preferably in science related field
• 2 years of experience working within an FDA regulated environment; 5 years of experience without a degree
• Prefer experience with industry based scientific testing methods (e.g. microbiological techniques, environmental monitoring, Karl Fischer residual moisture analysis, ELISA, sterility testing, endotoxin, etc.)
• Knowledge of AATB, FDA, and other state/federal regulations
• Knowledge of USP, ISO, AAMI, ANSI, ASTM standards

SKILLS/COMPETENCIES:

• Excellent oral, written, and interpersonal communication skills
• Proficient in Microsoft Office (e.g. Excel, Word, etc.)
• Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
• Must show aptitude to develop appropriate skills needed for the job