MANUFACTURING MANAGER – QL & QC -- Blood Services
Responsible for management and control of all daily laboratory operations, including all laboratory staff, budgets, environment and work processes. Assure compliance with safety policies and procedures in the work area and use applicable protective equipment at all times to prevent exposure to potentially infectious blood and body fluids. Comply with the Clinical Laboratory Information Act (CLIA). Perform all duties and responsibilities in compliance with standard operating procedures, Safety Quality Identity Potency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safety and Health Administration (OSHA) and other applicable Federal, state and local regulations.
Major Responsibilities: Responsible for the management of laboratory staff including, but not limited to, hiring, training, coaching, evaluating and disciplining to ensure a well-qualified team and to enhance operational success. Oversee planning process and ensure that long range goals are established for laboratory supervisory staff. Responsible for managing the budgetary process. Ensure all regulatory compliance in area or responsibility, as well as initiate actions to foster a quality driven environment. Serve as a resource for supervisors for complex technical issues. Coordinate the installation of new or revised tests and procedures, ensuring appropriate quality control in accordance with SOPs, CFR and OSHA regulations. Ensure compliance with state and federal regulations, AABB/ASHI standards, ARCBS directives and regional policies and procedures. Ensure laboratory training is completed in compliance with established guidelines. May assist in writing, organizing and maintaining technical sections of departmental procedure manual. May be responsible for the accuracy of computer and physical blood component inventories. Ensure staffing needs are met. Perform other related duties as necessary.
Scope: Accountable for prudent development and expenditure of total departmental operating budgets; recommends capital expenditures as needed. Operate under general guidelines from senior management. Plan own work and set priorities for department. Actions and decisions based on very broad precedent, discretion and judgment. Supervisory responsibility for multiple staff levels, including supervisors, professional staff and line staff.
Qualifications: Bachelor's degree in science, chemistry or Biology or equivalent experience, with MT (ASCP) certifications or equivalent certifications where required. SBB certification or Master’s degree preferred. Minimum five years laboratory experience required including two years supervisory experience. Good communication and computer skills required. Bachelors Degree in Engineering and a minimum of five years pharmaceutical industry experience in Process Engineering, Quality and Lean/Six Sigma principals will be considered. Essential
Functions/Physical Requirements: The duties are representative of the essential functions of the position. Operational flexibility is required to meet sudden and unpredictable needs. Available to work overtime, other shifts, early mornings, evenings, holidays and weekends. Requires standing, stretching, stooping and bending for extended time periods. Lift, pull, push and move objects of up to 75 pounds. May work in walk-in refrigerator/freezers for periods of time. Work under pressure and within time standards. Required to wear protective clothing such as lab coats, gloves, face shields, etc. when there is exposure to blood and blood products and/or where work location requires. Ability to use a wide variety of lab or medical equipment. Ability to use a personal computer and applicable software for sustained periods of time. Exposure levels are based on the essential functions as stated in this position description; however, in some instances, variances may occur due to the applicable nature of this position within a particular work site. Therefore the work site may determine the exposure level to be greater than or less than the below stated level.
This position is in OSHA Category I in view of the fact that the position requires the incumbent work under conditions where the potential exists for the incumbent to make contact with blood or blood components as a result of splashes, spills, and/or needlesticks. Potential exists to also be exposed to hazardous chemicals.
Dayshift M-F 40/wk. Ability to work flexible schedule when necessary, weekends, holidays etc.
Posting # 09-114
To apply, please mail your resume to:
Talent Acquisition
American Red Cross Blood Services
Attn: Yvonne Hackney
100 Mack,
Or apply on-line at: semresumes@usa.redcross.org