What are the responsibilities and job description for the Quality Control Technician position at MiMedx?

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 $23-28 / hr based on previous relevant experience, educational credentials, and location.

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

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Salary : $23 - $28

Apply for this job

Receive alerts for other Quality Control Technician job openings

Quality Control Technician

What are the responsibilities and job description for the Quality Control Technician position at MiMedx?

What is the career path for a Quality Control Technician?

Job openings at MiMedx

Not the job you're looking for? Here are some other Quality Control Technician jobs in the Marietta, GA area that may be a better fit.

We don't have any other Quality Control Technician jobs in the Marietta, GA area right now.

AI Assistant is available now!