Aequor | Assistant QC Scientist | warren, mi

2 days ago

warren, United States Aequor Full time

Assistant QC Scientist

Onsite Role: Warren, NJ

Contract Duration: 12 Months (with high possibilities of extension)

Work Schedule: Mon - Fri, 8:00 AM - 4:30 PM EST


Purpose

The QC Analyst is responsible for supporting Quality Control bioanalytical testing for the release of clinical and commercial products. This includes the ability to interface with multiple groups, independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will assist with training and assay transfer.


Hiring Manager's Preferred Candidate Qualifications

  • 2+ years of hands-on experience with bioanalytical techniques such as ELISA, Potency, Cell-based assays, etc.
  • 1+ year of experience working in a regulated environment (e.g., cGMP, cGLP).
  • Previous experience with assay transfer and assay validation.
  • CAR-T experience (preferred).
  • Technical understanding and troubleshooting abilities.
  • Knowledge of deviation, CAPA, and Change Control processes.
  • Team player with flexibility and strong communication skills.


Required Competencies: Knowledge, Skills, and Abilities

  • Hands-on experience with various bioanalytical techniques including ELISA, qPCR, FACS, and cell-based assays.
  • Experience in assay transfer, technology transfer, and validation from Analytical Development groups to Quality Control groups.
  • Strong understanding of Global Regulatory and cGMP requirements.
  • Technical writing proficiency.
  • Problem-solving mindset, technically adept, and logical.
  • Ability to represent the group's interests on cross-functional teams.
  • Strong prioritization and timeline management skills.
  • Effective communication with peers, department management, and cross-functional teams.


Duties and Responsibilities

  • Perform testing of in-process, final product, stability samples, and method transfer.
  • Apply scientific principles in analytical testing methods and proper use of laboratory equipment.
  • Anticipate and troubleshoot issues, recommend corrective actions, and contribute to best practices development.
  • Adhere to regulatory guidelines and complete all tasks in a timely manner.
  • Collaborate effectively with the team to meet deadlines.
  • Ensure all testing is compliant by applying technical knowledge and skills.
  • Provide feedback on review results and corrections needed.
  • Document training per procedural and cGMP requirements.
  • Perform assigned tasks within CAPA, deviation, or project contexts.
  • Draft and review technical documents, including SOPs and forms.
  • Communicate task progress, roadblocks, and needs to management.
  • Perform other tasks as assigned.


Education and Experience

  • Bachelor’s Degree: Required (preferably in Science).
  • Relevant Work Experience:
  • 2-3 years in a regulated environment is preferred.
  • Equivalent combinations of education and experience may be considered (e.g., a Master’s degree with 1-2 years of experience).


Working Conditions

  • Must distinguish colors and possess correctable vision to 20/20 (annual eye exam required).
  • Analyze numerical values daily.
  • Work in a laboratory setting for up to six (6) hours per day.
  • Work around biohazardous materials, including chemical agents, for up to six (6) hours per day.


Additional Information

This job description is intended to describe the general nature and level of work performed by individuals in this position. The primary duties and responsibilities listed are essential to the role but are not exhaustive. Other incidental or secondary duties may be assigned. Employees in this role will perform additional job-related tasks as requested by management.

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