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. 

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)

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