Assistant Manager Component Laboratory Job Locations US-MN-St. Paul ID 2024-6889 Category Component Lab Work Location Type Physical Type Regular Full-Time Overview Memorial Blood Centers (MBC.ORG), a division of Innovative Blood Resources (www.innovativebloodresources.org), has been saving and sustaining lives since 1948. We supply blood and blood components, state-of-the-art laboratory services, and biomedical expertise to area healthcare partners, national blood centers, biotechnology companies, research institutions, and international clients. Operating 10 donor centers and conducting hundreds of blood drives each month, we are proud to be an independent nonprofit that supplies over 30 area hospitals and more than a dozen air ambulances with life-saving blood-from our community, for our community. Responsibilities Summary: The Assistant Manager, Component Laboratory supervises personnel and coordinates operations associated with routine processing and testing of blood components. This person is expected to foster a positive working environment and to promote company values and initiatives. The Assistant Manager participates in staffing to ensure optimal operational efficiency and manufactures blood products when necessary. Assists management with projects, ordering vendor supplies, audit and inspection processes, and organizational projects. The Assistant Manager can qualify as the CLIA Technical Consultant if experience and educational criteria are met. The person in this position assists leadership to ensure that all work processes are performed and documented according to current Good Manufacturing Practices (cGMP) and within the guidelines of accrediting organizations (FDA, AABB, Octapharma, CLIA, etc.). Schedule: Mid/Second Shift Typically 11:00am - 7:30pm Monday - Friday Job Responsibilities: Leadership: Foster and promote a positive work environment in which staff members adhere to IBR values Support all IBR initiatives and objectives Co-lead organizational projects and process improvements Act as a departmental representative and actively participate at organizational meetings Designee as CL leadership at other IBR sites, when needed Facilitate synergy between departments, throughout the organization and enterprise Act as a departmental representative at IBR Leadership Team meetings Personnel: Hires, promotes, and evaluates staff Discipline staff Schedule staff for optimal operational efficiency Assist with providing staff with ongoing coaching and regular performance reviews Approve staff time off requests while ensuring staffing is sufficient to complete departmental tasks Quality Assurance: Manage deviations by investigating, ensuring appropriate corrective and preventive actions are complete, and documenting findings and actions in MC When qualified as a CLIA Technical Consultant, perform competency assessments of CLIA testing personnel on tasks that are CLIA-regulated testing Perform periodic reviews and changes of departmental controlled documents Write validation, verification, and qualification protocols Coordinate department response to audit findings and other CAPAs Review and submit CAP survey results online Act as departmental representative for auditors, assessors, inspections, and regulatory needs Prepare TWI and request variances for necessary immediate changes to controlled documents Financial: Initiate equipment and supply orders in the Oracle system Receive exception reports and reconcile with the payroll system Submit approved payroll on a bi-weekly basis Technical: Provide training to staff Act as a key staff designee Review updated package inserts and equipment users' manuals Ensure that all preventive maintenance on equipment is performed as scheduled Assist with implementation of new manufacturing processes Perform operational tasks, as needed Manage distribution and completion of competency assessments Review departmental records Qualify and perform as technical consultant for CLIA regulated instrumentation (degree/experience specific) Qualifications Education: Bachelor's Degree in Medical Technology, Clinical Laboratory Science, or Bachelor's Degree in Biological Sciences OR High school diploma and 5+ years of relavant experience Experience: 2 years relevant experience in laboratory training or in a moderate complexity testing environment 1 year experience in a supervisory or leadership role Other desired experience: Experience in a cGMP regulated environment Ability to teach others Excellent customer service and descision making skills Excellent oral and written skills Innovative Blood Resources is an equal employment/affirmative action employer and does not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, marital/or parental status, age, national origin, citizenship, disability, veterans status, or any other classification protected by applicable Federal, State, or Municipal Law. If you require assistance or accommodations completing our application process, please contact our human resource department at 651-332-7000, Monday thru Friday 10-4. We are unable to return phone calls related to checking on the status of job applications successfully submitted electronically.