QC Coordinator - Sample Aliquoting

Location
Harmans, MD, US
Posted
Jul 19, 2019
Ref
1687
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

Key Responsibilities include but are not limited to:

  • Respond to other department inquiries regarding status of aliquoting requests
  • Preparation of labels and label vials for samples
  • Reconstitution and aliquoting of samples
  • Sample coordination and receipt from other departments for internal and external testing
  • Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures
  • Receive Batch Records and Test Request forms from other departments
  • Order and receive supplies for groups as necessary
  • Execute document revisions
  • Works closely with Manufacturing for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination.
  • Ensure adequate stock of aliquoting supplies through forecasting of upcoming sample submission
  • Assist in preparing of samples for shipment to contract laboratories
  • Assist with tracking sample receipt and chain of custody for internal and contract laboratory submission
  • Work under general supervision to meet project goals
  • Flexibility in following unique campaign requirements that may include off-hour and weekend work
  • Assist with tracking internal / external testing as necessary
  • Assist with QC reagent preparation as necessary
  • Perform laboratory cleaning as part of routine work
  • Assist with maintaining inventory of QC non-critical and critical reagents as necessary
  • Perform QC document archival activities (i.e. submission and requests to Document Control department)
  • Other duties as assigned

Education & Experience:

  • A.S. in a Life Sciences discipline preferred and a minimum of 2 years of relevant experience working in a cGMP environment
  • Experience working in cGMP Quality Control
  • Strong attention to detail and strong organizational skills
  • Strong written and verbal communication skills
  • Have the knowledge and ability to apply basic scientific and regulatory principles to solve operational and other routine quality tasks.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

#LI-EW1