QA Laboratory Manager
3 days ago
Englewood
Job Description Would you like to develop your skills working for a mission-driven organization while playing an important role in leading the way in Life Sciences? AlloSource is a BioTech company headquartered in Centennial, Colorado. Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life! If this sounds like an organization you wish to be a part of, then we invite you to apply Summary: The Quality Assurance Laboratory Manager plans, supervises and coordinates the technical and administrative activities required in support of the procurement and processing activities including bacteriological analysis, testing of products for compliance to release criteria, and coordination of contract laboratory testing, ensure required Microbiology testing and studies support new product development, maintains CLIA Certification, support upper management in QAL budget decisions and support contract laboratory operations. Anticipated Application Deadline: October 31, 2025 Pay: $83,282yr - $103,039/yr based upon years of relevant experience Shift: Monday-Friday; 8:00am to 5:00pm Benefits: Medical, Dental, Vision, Life Insurance. Click link for more benefits details: 2025 AlloSource Employee Benefits Summary Location: 6278 S Troy Circle Centennial, Colorado 80111 Essential Duties and Responsibilities: Leadership: • Provide microbiological and laboratory subject matter expertise to the company and QAL sub-teams., • Provide leadership, mentorship, and guidance to supervisors and laboratory teams., • Review standards and compendia to ensure regulatory compliance with testing requirements., • Ensure laboratory compliance with CLIA, ISO, and FDA requirements and maintain laboratory regulatory registrations., • Manage microbiological input into the Aseptic Processing Program., • Establish a training and internal competency program within the department., • Manage external proficiency testing of laboratory personnel., • Develop new or redefined processes for current and new testing for the QAL Department., • Manage the Microbiology and analytical processes and personnel in the laboratory., • Review, approve, and monitor LIMS outputs and Power BI dashboards for the Quality Assurance Laboratory., • Delegate project activities to appropriate laboratory personnel, e.g, LIMS, assay development., • Provide microbiological and laboratory subject matter expertise to the company and QAL sub-teams., • Provide leadership, mentorship, and guidance to supervisors and laboratory teams., • Support and monitor laboratory budget/cost for the QAL Department., • Maintain adequate staffing levels, conduct performance appraisals, and career development assessments., • Support Quality systems as assigned and lead laboratory personnel with quality system responses, inputs, outputs, and closures (i.e. CAPA, NCR, case management)., • Lead critical and major investigations with issues impacting aseptic processes or contamination., • Manage and monitor team activities for the timeliness of completion of documentation, workload distribution, and project resourcing., • Serve as laboratory and microbiology SME with internal, customer, and regulatory audits., • Ensure laboratory safety program is maintained and enforced., • Manage and oversee the simulation process by establishing a calendar for annual review of results surrounding each product type. As well as oversee the execution of process simulation for new processes., • Maintain and oversee sterilization validation and dose audit processes., • Professionally interact and communicate with internal and external customers/vendors, laboratories, and process stakeholders., • Drive a quality vision of continuous process improvement and support new product development., • Assist upper management with cost-reduction and improved efficiency in the laboratory while maintaining customer satisfaction and high-level standards., • Lead in the development, evaluation, and review of policies, procedures, and methodologies for the laboratory to maintain compliance with accreditation., • Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices, and company policies, • Bachelor’s degree in microbiology, Medical Technology, or related field, • 5-7 years’ laboratory experience within Regulated Laboratory, Tissue Banking, Medical Device, Food, or pharmaceutical industries, • 1+ year Laboratory Information Management System (LIMS) experience., • Hands-on microbiology methods and workflows experience (e.g., Bacteriostasis / Fungistasis, Enhancement and Inhibition, LAL, Sterility, and Bioburden testing)., • FDA/ISO/CLIA audit experience, • Environmental Monitoring and Cleanroom Testing experience, • Technical writing, • 3-5 years’ supervisory experience, • Proficiency in Microsoft Office applications, • Master’s degree in a scientific field, • ASQ certification, • AATB certification, • Environmental monitoring lab experience, • Experience with Quality Management System software, • Tissue Banking experience, • Project Management experience, • Operational Excellence of a Microbiology Laboratory, • Planning and Management of Budgets It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. If you need reasonable accommodation to apply for a position, please contact us at 720-873-0213. For consideration you must apply online, submit a current resume and meet the minimum requirements. Candidates within a 50-mile radius of the hiring zip code may receive first consideration. Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. 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 .