QC 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 to hire

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 production. This position necessitates a solid understanding of scientific principles, methodologies, and practices within the biopharmaceutical sector, particularly in a cGMP setting. The QC Scientist will primarily support the daily operations of the GMP facility, including analytical development, batch release, and stability assessments.

Key Responsibilities:

  • Conduct analytical evaluations as required by the QC Laboratory for assessing raw materials, components, and products throughout various stages of the manufacturing process, 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 necessary.
  • Calibrate, validate, or maintain laboratory instruments as required.
  • Ensure accuracy and regulatory compliance in laboratory data management, including oversight of contract laboratories.
  • Perform additional duties as assigned.

Qualifications:

  • 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 knowledge of cGMP being advantageous.
  • Strong expertise in QC analytical techniques utilized in cell therapy manufacturing, including qPCR/dPCR, ELISA, flow cytometry, or cell-based assays in a GMP context.
  • Proficient in technical writing for SOPs and analytical test methods, as well as documentation for method qualification and validation.
  • Excellent communication skills, both written and verbal, along with strong interpersonal abilities.

Preferred Skills:

  • Self-motivated individual with exceptional analytical and problem-solving capabilities.
  • Proficient in the MS Office suite.
  • Demonstrates a thorough understanding of current Good Manufacturing Practice (GMP).
  • Effective communicator with the ability to convey information and influence others.
  • Exhibits a strong work ethic, dependability, and punctuality.
  • Possesses a high energy level and a positive attitude.

About IntelliPro:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our dedication to providing exceptional service to clients, nurturing employee development, and fostering lasting partnerships distinguishes us in the industry. With a strong 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 compensation offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. IntelliPro also provides a comprehensive benefits package, subject to eligibility.

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