Assistant Manager Component Laboratory
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