Plasma Center Director

Location: Bedford, TX
TRAVEL :
  • Must be willing to travel
  • This position will require travel to the Green Acres, FL location until June 2018 when the facility opens.
  • Travel schedule: 3 weeks blocks in Green Acres, FL and work from home for 1 week until the new facility opens.

ESSENTIAL JOB FUNCTIONS:
  • Create appropriate organizational environment and value system, which stimulates the morale and productivity of the work force and its leadership.
  • Provide strategic direction, planning and customer focus.
  • Establish and maintain the ability to perform any/all tasks within the plasma center; fulfill role of production employee when the need arises.
  • Monitor and evaluate operations.
  • Ensure collected products and samples are stored and maintained in accordance with established regulations, customer requirements and SOP's.
  • Maintain and monitor freezer performance including after hours on call responsibilities and vendor relationships needed for emergency freezer repair services and product temperature maintenance e.g. dry ice supplier.
  • Assist in budget preparation and then manage facility against the agreed-upon budget.
  • Organize, develop, and utilize management team. Develop a "partnership" with the Quality Supervisor(s) to promote productive interactions between Operations and Quality personnel.
  • Maintain thorough familiarity with State and Federal regulations, European regulations, FDA approved Standard Operating Procedure manual, OSHA, CLIA, and cGMP.
  • Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, European regulations, FDA approved Standard Operating Procedure manual, OSHA, CLIA, and cGMP, through systems in place and via QA/Training Programs.
  • Responsible for all personnel functions including hiring, development and training, disciplinary actions and termination, and maintenance of all personnel records.
  • Maintain adequate inventory of all goods and supplies necessary for center operation to include order goods as needed.
  • Assure facility is maintained in a neat and clean condition and all equipment is kept in good working order.
  • Submit timely and accurate reports as necessary, including payroll and accounts payable management.
  • Develop an effective donor recruitment advertising campaign to improve production levels.
  • Control facility donor funds.
  • Keep immediate supervisor informed of any irregularities within the center and provide constructive information about process improvements.
  • Minimize center liability through constant risk management review.
  • Signed Statement of Responsibility and Curriculum Vitae on file at the center and authorized official's office.
  • Ensure all collected products are test tested prior to release, product recalls and corresponding documents are completed on time and ensure shipments of collected plasma occur timely and in accordance with all regulatory requirements.
  • Responsible for maintaining a consistent, regular attendance record.
  • May be required to work weekends, evenings, unusual hours during the night and some holidays.

Additional Duties and Responsibilities:
  • Performs other duties as assigned, including but not limited to, cleaning of all areas of the center, receiving and shipping of products and materials,
  • May be assigned to train or work with new employees.
  • May be assigned to assist in other areas as needed.
  • Maintains open to close operational coverage and control over daily manufacturing activities.

SUPERVISORY RESPONSIBILITIES:
  • Directly and indirectly supervises all Donor Center employees.
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

MINIMUM EDUCATION and/or EXPERIENCE:
  • PhD and 2 years’ experience in applicable clinical lab area or MA/MS with major in medical technology or one of the biological, physical, or chemical sciences and four years’ experience in clinical lab required.
April A. Estes
Senior Recruiter
720-439-2609 Direct
april@proenlist.com 
www.proenlist.com 
www.medenlist.com 

www.linkedin.com/in/aprilaestes
 
or
this job portal is powered by CATS