Scientist - Analytical Testing Specialists

AR Validation Services

  • Mansfield, MA
  • Today
  • $50–$55 Per Hour
  • Contractor

Highlights

The successful candidate will support product release, stability testing, analytical method execution, laboratory investigations, data review, and GMP-compliant documentation while ensuring adherence to quality and regulatory requirements. The ideal candidate will have 5–7 years of experience in a regulated GMP environment and demonstrated proficiency in HPLC, GC, dissolution testing, UV/Vis spectrophotometry, wet chemistry, and routine pharmaceutical analytical testing.

Numbers & Facts

LocationMansfield, MA
Job TypeContractor
Salary$50–$55 Per Hour

Description

We are seeking an experienced Scientist – Analytical Testing Specialist with strong hands-on expertise in pharmaceutical quality control and analytical laboratory testing. The ideal candidate will have 5–7 years of experience in a regulated GMP environment and demonstrated proficiency in HPLC, GC, dissolution testing, UV/Vis spectrophotometry, wet chemistry, and routine pharmaceutical analytical testing.

The successful candidate will support product release, stability testing, analytical method execution, laboratory investigations, data review, and GMP-compliant documentation while ensuring adherence to quality and regulatory requirements.

Job Responsibilities

Perform routine pharmaceutical analytical testing using HPLC, GC, dissolution, UV/Vis, and wet chemistry techniques.
Execute analytical methods in accordance with approved procedures, specifications, protocols, and GMP requirements.
Support finished product, raw material, in-process, and stability testing, as applicable.
Perform analytical testing to support product release and stability programs.
Review analytical data, chromatograms, calculations, laboratory records, and test results for accuracy and completeness.
Conduct and support laboratory investigations, including atypical results, deviations, and out-of-specification (OOS) investigations.
Prepare and maintain accurate laboratory documentation in accordance with GMP and data integrity requirements.
Ensure proper operation, routine maintenance, and troubleshooting of analytical laboratory instruments.
Follow approved SOPs, analytical methods, safety procedures, and quality standards.
Maintain laboratory readiness, including equipment, reagents, standards, worksheets, and controlled documentation.
Ensure analytical activities are completed accurately and within established timelines.
Collaborate with Quality Assurance, Manufacturing, R&D, and other cross-functional teams as required.
Identify opportunities for improving laboratory processes, analytical methods, and testing efficiency while maintaining compliance.
Support audits and regulatory inspections by providing appropriate laboratory records and technical information.

Qualifications

Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline.
5–7 years of hands-on experience in pharmaceutical quality control and analytical laboratory testing.
Experience working in a regulated GMP environment, preferably within pharmaceutical manufacturing or quality control.
Demonstrated experience with HPLC, GC, dissolution testing, UV/Vis spectrophotometry, and wet chemistry.
Experience supporting pharmaceutical product release and stability testing.
Strong understanding of pharmaceutical analytical testing methodologies and laboratory practices.
Experience with laboratory investigations, data review, deviations, and OOS/OOT investigations.
Working knowledge of GMP, data integrity, ALCOA+ principles, and laboratory documentation requirements.
Ability to independently execute analytical methods and accurately interpret test results.
Strong attention to detail and commitment to quality and compliance.
Good written and verbal communication skills.

Skills

  • HPLC and Chromatographic Analysis
  • Gas Chromatography
  • DISSOLUTION TESTING
  • UV/Visible Spectrophotometry
  • Wet Chemistry & Titration Techniques
  • Pharmaceutical Quality Control Testing
  • Analytical Method Execution
  • Stability & Release Testing
  • Laboratory Investigations
  • OOS/OOT & Deviation Investigations
  • Analytical Data Review
  • GMP & GDP Compliance
  • Data Integrity / ALCOA+
  • SOP and Laboratory Documentation
  • Analytical Instrument Operation & Troubleshooting
  • Root Cause Analysis
  • TECHNICAL REPORT WRITING

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