Quality Control Scientist I

2 weeks ago

Rockville, Maryland, United States IntelliPro Group Inc. Full time
Job Overview

Position Title: Scientist I, Quality Control (QC)

Employment Type: 12-month contract with potential for permanent placement

Work Location: Onsite

Compensation Range: $32-$37/hr

Job Summary:

The Scientist I in Quality Control plays a pivotal role in supporting the Quality Control department at our GMP facility. This position requires a solid understanding of scientific principles and practices within the biopharmaceutical sector, particularly in a cGMP setting. The QC Scientist will be instrumental in facilitating the day-to-day operations of the GMP facility, focusing on analytical development, batch release, and stability assessments.

Key Responsibilities:

  • Conduct analytical evaluations as mandated by the QC Laboratory for assessing raw materials, components, and products throughout various manufacturing phases, adhering to established ATMs or SOPs.
  • Engage in activities outlined in method transfer, qualification, validation, and stability study protocols.
  • Analyze, interpret, and report data in compliance with GDP and ALCOA standards.
  • Participate in investigations regarding deviations, OOS/OOT results, CAPA, and related activities.
  • Draft, review, and update SOPs and ATMs as required.
  • Calibrate, validate, or maintain laboratory instruments as necessary.
  • Ensure accuracy and regulatory compliance of laboratory data, including that from contract laboratories.
  • Undertake additional tasks as assigned.

Qualifications:

  • Bachelor of Science (Master's preferred) in a Life Sciences field with 1-3 years of relevant experience in a Quality Control environment, ideally within the pharmaceutical industry, with knowledge of cGMP considered advantageous.
  • Demonstrated expertise in QC analytical methodologies pertinent to cell therapy manufacturing, including qPCR/dPCR, ELISA, flow cytometry, or cell-based assays in a GMP context.
  • Proficient technical writing skills for SOPs and analytical test methods, along with experience in method qualification and validation documentation.
  • Strong written and verbal communication skills, along with effective interpersonal abilities.

Preferred Qualifications:

  • Self-motivated individual with exceptional analytical and problem-solving capabilities.
  • Proficient in the Microsoft Office suite.
  • Demonstrated knowledge of current Good Manufacturing Practices (GMP).
  • Effective communication skills to convey information and influence others.
  • Exhibit a strong work ethic, reliability, and punctuality.
  • Possess a high energy level and a positive attitude, complemented by a proactive approach.

About IntelliPro Group Inc.:

Founded in 2009, IntelliPro Group Inc. is a leader in talent acquisition and HR solutions. Our dedication to providing exceptional service to clients, promoting employee development, and fostering long-lasting partnerships distinguishes us in the industry. With a robust presence across multiple countries, we continue to excel in delivering global talent solutions.

As an Equal Opportunity Employer, IntelliPro values diversity and is committed to creating an inclusive environment for all candidates. We do not discriminate based on any legally protected status and ensure our hiring processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity.

Compensation: The compensation for successful candidates will be determined based on various factors, including education, experience, location, job responsibilities, and certifications. IntelliPro also offers a comprehensive benefits package, subject to eligibility.

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