The Quality Control Technician has the responsibility and authority to approve or reject tissue, as well as discontinue Processing and/or release of tissue. Responsible for handling technical aspects of AlloSource’s Quality Control Program within the Controlled Work Area, Donor Receiving, Vessel Manufacturing, and Final Labeling. This includes the review of processing records, completion of quality documents, and visual inspections of in process and final labeled tissue, in accordance with all applicable regulatory standards. Frequent communication with multiple departments is an integral part of the job.
Essential Duties and Responsibilities:
- Evaluate session/batch records and outputs for approval and ensure that any corrections are identified and completed prior to acceptance. (Move to TE after Osteocel, DeNovo, VersaWrap).
- Assist Management in collection of data, analysis of data, and report development.
- Uses critical thinking skills to coordinate decisions for corrections, implements correction or elevates as necessary.
- In-process CWA Rework evaluation and disposition.
- Completes NC investigations, Case Entry and Incident Reporting.
- Review of DCR reports/request corrections as needed.
- Identifies areas for process improvement, completes change control process to implement process improvements.
- Observe and/or audit in-process Production to verify specification and work instruction adherence, and communicate required adjustments to those responsible.
- Maintain safe work environment by following procedures and wearing appropriate PPE.
- Involved in making quality decisions about products based on requirements outlined in SOPs, WIs, and Specs.
- Participate in projects impacting production, inventory or evaluation and maintain consistent cross-functional communication with all departments, shifts and management.
- Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
- High School diploma or equivalent
- 2-3 years’ Quality Assurance or Quality Control experience working in a regulated industry
- Proficiency in Microsoft Office applications
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
Equal Opportunity Employer/Veterans/Disability
AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.