Analytical Scientist I, Quality Assurance

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 to hire

Work Location: Onsite

Compensation Range: $32-$37/hr

Job ID: 136774

Role Summary:

The Scientist, QC role is integral to the Quality Control team at our GMP facility, focusing on IND and Phase I/II GMP manufacturing processes. This position demands a solid understanding of scientific principles, methodologies, and practices within the biopharmaceutical sector, particularly in a cGMP setting. The QC Scientist will primarily assist in the seamless operation of the GMP facility, engaging in 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 stages, 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.
  • Investigate deviations, OOS/OOT results, CAPA, and related activities, contributing to reporting and resolution.
  • Draft, review, and update SOPs and ATMs as necessary.
  • Calibrate, validate, or maintain laboratory instruments as required.
  • Oversee and ensure the accuracy and regulatory compliance of laboratory data, including that from contract laboratories.
  • Perform additional duties as assigned.

Qualifications:

  • Scientist I: Bachelor of Science (MS preferred) in a Life Sciences discipline with 1-3 years of relevant experience in a Quality Control environment, ideally within the pharmaceutical industry, with familiarity in cGMP.
  • Strong expertise in QC analytical methods applicable 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, as well as method qualification and validation documentation.
  • Exceptional written and verbal communication skills, along with strong interpersonal abilities.

Preferred Qualifications:

  • Self-motivated individual with excellent analytical and problem-solving capabilities.
  • Proficient in the MS Office suite.
  • Demonstrated knowledge of current Good Manufacturing Practice (GMP).
  • Strong communication skills to convey information effectively and influence others.
  • Exhibit a strong work ethic, dependability, and punctuality.
  • Possess a high energy level and a positive attitude.

About IntelliPro:

Founded in 2009, IntelliPro is a leading provider of talent acquisition and HR solutions. Our dedication to exceptional client service, employee development, and 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 is committed to diversity and does not discriminate based on any legally protected status. Our Inclusivity Commitment ensures that we embrace candidates of all abilities and accommodate the needs of all applicants throughout our hiring and interview processes.

Compensation: The salary offered to successful candidates will be determined by various factors, including education, experience, location, job responsibilities, and certifications. IntelliPro also provides a comprehensive benefits package, subject to eligibility.

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