Quality Control Specialist I

2 weeks ago

Stony Brook, New York, United States Executive Alliance Full time
Job Overview

Our client, a prominent and expanding biotechnology firm located in Suffolk County, is at the forefront of developing innovative technologies for DNA and RNA production and detection.

Position: Quality Control Specialist I - Life Sciences

This Long Island-based biotechnology organization specializes in DNA production and detection across various product lines. They provide competitive compensation, excellent benefits, and a unique opportunity to work with DNA technologies that are uncommon in this region.

The Quality Control (QC) Specialist I plays a crucial role in initiating and coordinating quality-related data from Production, Research and Development, or process enhancement activities, compiling these findings into a comprehensive QC Report. The QC Specialist I collaborates closely with the Senior Manager of Quality Control to implement and execute Quality Control protocols, methodologies, and documentation necessary to assess product quality and readiness for release. This role requires effective communication with the Senior Manager of Quality Control, Production, Project Management, Operations, and Quality Assurance and Compliance teams to ensure commitments and functional requirements for tested materials are met.

Key Responsibilities:

  • Achieve departmental goals and objectives, ensuring compliance with internal and external commitments.
  • Review incoming samples and accompanying documentation for completeness and accuracy upon acceptance into the Quality Control Laboratory.
  • Conduct Quality Control testing on incoming raw materials and outgoing finished products, applying scientific principles for analysis, identification, and classification of samples, while strictly adhering to standard operating procedures (SOPs).
  • Generate detailed and accurate reports utilizing computer and software skills, distributing these reports to relevant stakeholders within the organization.
  • Execute laboratory investigations and summarize findings in a comprehensive report.
  • Perform thorough technical reviews of Quality Control Reports.
  • Operate and maintain essential laboratory equipment and apparatus.
  • Manage a cloud-based remote environmental monitoring system for QC laboratory spaces.
  • Oversee current lab inventory while anticipating future purchasing needs for the QC laboratory.
  • Assist the Senior Manager of Quality Control in revising and reviewing documentation, including quality procedures, specifications, and SOPs.
  • Maintain QC-related documents on cloud storage platforms.
  • Collect, organize, monitor, and disseminate information pertinent to quality and process improvement functions, including compliance with quality management standards such as ISO 9001.
  • Support internal and external audits of the QC laboratory.
  • Participate in ISO-related certification and accreditation programs, collaborating closely with Forensics, Production, Research and Development, and Quality Assurance teams.

Qualifications:

To excel in this role, candidates must demonstrate the ability to perform each essential duty satisfactorily. The following qualifications are representative of the knowledge, skills, and abilities required:

  • Bachelor's degree or equivalent in life/physical sciences or a technical discipline, along with one to two years of relevant experience and/or training, or an equivalent combination of education and experience.
  • Prior laboratory experience, preferably in a Quality Control environment, is preferred. Familiarity with laboratory equipment and processes, including but not limited to HPLC (highly desirable), FT-IR, Capillary Electrophoresis, and PCR (end-point, digital, and quantitative), is also advantageous.
  • If prior Quality Control experience is lacking, this should be documented and supplemented with additional training in the analytical methodologies, platforms, and interpretations of DNA results utilized by the laboratory.
  • Working knowledge of ISO or similar compliance programs is a plus.
  • Proven ability to prioritize, plan, track, execute, and document multiple projects and/or experiments concurrently.

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