Quality Control Technician

At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.

We are excited to add an Quality Control Technician to our Quality Control team! The position will pay between $20-28/hr based on previous relevant experience and other factors.

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 microbial tests on donor culture samples, environmental samples and related supplies:
  
  
  
  • 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
  • Media suitability tests (i.e. growth promotion and sterility) to ensure incoming media (both liquid and plate media) used to grow bacteria/fungi are not contaminated and are able to sustain microbial growth
  
  
  
  
• 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 equipment cleaning (e.g. incubators, refrigerators, carbon analyzers, etc.) used to perform quality control tests and/or in the manufacture of tissue products, as scheduled
• Conduct well-defined, standardized testing of processing suites, water systems and manufactured products, such as:
  
  
  
  • Monitoring of controlled environmental areas (CEA), testing of air and surfaces for the presence of organisms and free-floating particulate to ensure required 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 products 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

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:

• 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

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:

• Batchelor's degree in a science related field preferred
• Minimum of 2 years of experience working within an FDA regulated environment; 5+ years of experience without a degree
• Experience with microbiology related testing (e.g. microbiological techniques, micro identification, bioburden, sterility, endotoxin, ELISA, environmental monitoring, etc.) strongly preferred
• Knowledge of AATB, FDA, and other state/federal regulations
• Knowledge of USP, ISO, AAMI, ANSI, ASTM standards

SKILLS/COMPETENCIES:

• Strong written, verbal, and interpersonal communication skills
• Proficient in Microsoft Office (Excel, Word, etc.)
• Highly organized, detail-driven, and able to manage multiple priorities
• Demonstrated ability to learn and apply new technical skills

WORK ENVIRONMENT/EXPECTED BUSINESS TRAVEL:

• Work is performed in laboratory settings, controlled environments, warehouse, and office spaces
• Hands-on use of lab equipment and inspection tools is required
• Reliable transportation is needed for travel between nearby facilities (approximately 8 miles)

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to, or requirements for, this job at any time.