Associate III, Manufacturing

American Red CrossGaithersburg, MD
Onsite

About The Position

The Diagnostic Manufacturing Division (DMD), an FDA licensed manufacturer of blood banking reagents, is seeking an experienced blood banker as a new product development specialist. The role involves advanced manufacturing processing procedures for blood banking reagents, including finishing and distribution. Responsibilities include designing, performing, and interpreting experiments for new product development, as well as designing forms, records, and verification/validation studies and protocols. The specialist will establish requirements, identify formulations, and verify/validate new product performance. Excellent written, computer, and verbal communication skills are essential for customer interaction, coordinating field testing trials, and writing standard operating procedures and FDA submissions. The DMD team collaborates to supply 44 Red Cross Immunohematology Reference Labs with quality, cost-effective blood banking reagents. The position is located in Gaithersburg, Maryland.

Requirements

  • Bachelor's degree or equivalent combination of education and related experience required.
  • Minimum 5 years blood banking experience or equivalent combination of education and related Medical Technology or related field experience required.
  • Ability to work on a team.
  • Regularly required to sit; use hands to handle or feel; and talk or hear.
  • Frequently required to reach with hands and arms.
  • Occasionally required to stand; walk and stoop, kneel, crouch, or crawl.
  • Must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 30 pounds.
  • Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • Ability to work in a small cubicle and have the ability to sit at a computer terminal for an extended period of time.

Nice To Haves

  • MLS or MLT (ASCP) preferred.

Responsibilities

  • Perform advanced manufacturing processing procedures to produce a variety of blood banking reagents.
  • Learn all aspects of reagent production including finishing and distribution.
  • Design, perform, and interpret experiments for new product development.
  • Design forms, records, and verification/validation studies and protocols.
  • Establish requirements, identify formulations, and verify and validate performance of new products.
  • Communicate with customers, coordinate field testing trials, and write standard operating procedures and submissions to the FDA.
  • Collaborate with the DMD team to supply Red Cross Immunohematology Reference Labs with quality, cost-effective blood banking reagents.

Benefits

  • Medical, Dental Vision plans
  • Health Spending Accounts & Flexible Spending Accounts
  • PTO: Starting at 15 days a year; based on type of job and tenure
  • Holidays: 11 paid holidays comprised of six core holidays and five floating holidays
  • 401K with up to 6% match
  • Paid Family Leave
  • Employee Assistance
  • Disability and Insurance: Short + Long Term
  • Service Awards and recognition
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