QC Sample Coordinator

7 days ago

Durham, North Carolina, United States Asklepios Biopharmaceutical Full time
Job Title: Sample Coordinator

As a Sample Coordinator at Asklepios BioPharmaceutical, Inc., you will play a critical role in ensuring the quality and integrity of our samples. This position requires a high level of attention to detail, excellent organizational skills, and the ability to work independently in a fast-paced environment.

Responsibilities:
  • Perform GMP tasks associated with maintaining compliant quality control, analytical development, and stability laboratories as it pertains to sample management.
  • Ensure all samples are properly received, inspected, stored, and inventoried.
  • Log incoming samples into LIMS, print and label sample tubes, aliquot samples, and update and maintain LIMS sample inventory.
  • Own, initiate, and author deviations, CAPAs, and Change Controls related to sample movement/management.
  • Author new SOPs and revise existing SOPs as needed.
  • Support continuous improvement of Sample Management procedures by independently identifying process gaps.
  • Recognize the impact of procedural changes that may impact future quality tasks and decisions.
  • Support ordering, receipt, and storage of general lab consumables and reagents.
  • Coordinate all out-sourced sample testing, to include communication with all internal and external stakeholders about sample shipments, sample processing, and distribution of testing results.
  • Act as Single Point of Contact with all third-party testing vendors and shippers.
  • Act as Single Point of Contact with Project Managers, Material Depots and Producers, Material Shippers, and Analytical Development Project Leads to coordinate shipment and receipt of samples.
  • Interact with regulatory agencies as the subject matter expert for sample handling related inquiries.
Requirements:
  • Associate's and 3+ years of relevant industry experience or Bachelor's and 1+ year of industry experience.
  • Experience in regulated GMP Quality Control laboratory within the pharmaceutical or biotech industry.
Preferred Qualifications:
  • Ability to handle multiple projects/teams simultaneously.
  • Ability to work independently in a fast-paced, highly interactive environment with minimal supervision.
  • Excellent verbal and written communication skills.
  • Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
  • Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams.

Asklepios BioPharmaceutical, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements.

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