QC DNA Analyst

5 days ago


Wilmington, Delaware, United States Biolog Inc Full time
Job Title: QC DNA Analyst

We are seeking a detail-oriented and collaborative QC DNA Analyst to join our growing team at Biolog Inc.

Job Summary:

The QC DNA Analyst will be responsible for performing data analysis and quality control checks on all outgoing Certificates of Analysis (CofAs) and reports. This role requires a strong understanding of DNA sequencing, MALDI-TOF, and microbiology lab techniques.

Key Responsibilities:
  • Evaluate DNA sequencing data, draw identification conclusions, and generate/sign/verify reports to ensure accuracy and completeness.
  • Evaluate MALDI-TOF data, form identification conclusions, and sign/verify reports before release.
  • Perform thorough quality control checks on all outgoing reports and Certificates of Analysis (CofAs), ensuring compliance with company, regulatory, and cGMP standards.
  • Assist in data analysis by working closely with the laboratory team, helping to troubleshoot any issues that may arise during sequencing and MALDI-TOF analysis.
  • Support the assembly of raw Sanger sequencing data into consensus sequences using DNA assembly software.
  • Contribute to continuous improvement by suggesting process optimizations and participating in team discussions aimed at enhancing quality and efficiency.
  • Ensure full adherence to all Quality System Procedures (QSP) while analyzing data, following cGMP principles and ISO 17025 regulatory requirements.
  • Maintain clear, effective communication with customers, providing detailed report interpretations and addressing any questions or concerns. Escalate inquiries outside your expertise to management as needed.
  • Participate in cross-functional team activities and collaborate with colleagues in the laboratory and quality assurance departments to meet business objectives.
  • Be proactive in assisting team members with workload distribution, problem-solving, and ensuring timely completion of tasks.
  • Stay current with industry standards and continuously seek out ways to enhance both personal and team performance.
  • Support the Quality team in internal and external audits, process improvements, and other duties as assigned to meet business needs.
Requirements:
  • Bachelor's degree in Life Science or Biotechnology with 2+ years of relevant experience, or Master's degree in Life Science with 1+ year of relevant experience.
  • Knowledge of Laboratory Information Management Systems (LIMS) and proficiency in the Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
  • Technical knowledge of DNA sequencing, MALDI-TOF and microbiology lab techniques.
  • Familiarity with working in an ISO 17025, cGMP lab environment.
  • Strong attention to detail, with a commitment to maintaining the highest levels of accuracy and quality.
  • Excellent communication skills, both written and verbal, to effectively collaborate with team members and interact with customers.
  • Team-oriented mindset, willing to work collaboratively to achieve common goals.
  • Ability to multitask, prioritize workload, and manage time efficiently in a fast-paced environment.
  • Self-starter who is proactive in managing responsibilities while working within a team environment.


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