Pharma QC Scientist – Analytical Chemistry Expert

Olon Ricerca Bioscience Llc

Concord (OH)

On-site

USD 55,000 - 85,000

Full time

3 days ago
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Job summary

Olon Ricerca Bioscience Llc is seeking a detail-oriented QC Associate Scientist in Concord, OH to support analytical testing of raw materials, in-process samples, finished products, and stability samples in a cGMP-regulated lab.

The role involves data review, investigations (OOS/OOT), CAPA support, and preparation of protocols and reports, ensuring regulatory alignment with ICH, FDA, and EMA standards. Strong lab instrumentation experience and teamwork are required.

Qualifications

  • Bachelor's degree in Chemistry or a related scientific discipline.
  • 3+ years of related pharmaceutical analytical laboratory experience with a B.S. degree, or 1 year with an M.S. degree, or an equivalent combination of education and experience.
  • Relevant experience in a Quality Control laboratory is required.
  • Experience working in a cGMP and/or GLP-regulated environment is required.

Responsibilities

  • Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using HPLC, GC, KF, FTIR, XRD, DSC, TGA, PSD, NMR, ICP-MS, ICP-OES, and other laboratory instrumentation as required.
  • Support stability programs through sample management, stability chamber monitoring, testing, and generation of stability data.
  • Coordinate timely and compliant generation of analytical data to support client projects and manufacturing operations.
  • Review laboratory data for technical accuracy, completeness, compliance, and adherence to good documentation practices.
  • Conduct OOS, OOT, and laboratory investigations and support implementation of corrective and preventive actions (CAPAs).
  • Author and review protocols, reports, specifications, analytical methods, and related laboratory documentation.
  • Perform raw material sampling, testing, inspection, and coordination activities as required.
  • Manage laboratory inventory, retained samples, reagents, standards, chemicals, and associated laboratory systems.
  • Collaborate with Quality Assurance, Manufacturing, and Clients to support analytical testing, batch release, and stability studies.
  • Maintain compliance with cGMP, GLP, ICH, FDA, EMA, and other applicable regulatory requirements.
  • Other duties as assigned.

Skills

Laboratory equipment proficiency
QC testing experience
OOS/OOT investigations
Data analysis & statistics
Word & Excel proficiency
Communication & teamwork
Multi-tasking in fast-paced env
Chemistry fundamentals

Education

Bachelor's degree in Chemistry or related field
3+ years pharma analytical lab or 1+ year with MS in same
cGMP/GLP experience

Job description

Olon Ricerca Bioscience Llc is seeking a detail-oriented QC Associate Scientist in Concord, OH to support analytical testing of raw materials, in-process samples, finished products, and stability samples in a cGMP-regulated lab.

The role involves data review, investigations (OOS/OOT), CAPA support, and preparation of protocols and reports, ensuring regulatory alignment with ICH, FDA, and EMA standards. Strong lab instrumentation experience and teamwork are required.

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