Quality Control Analyst

Arcadis; Boston (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

Arcadis is seeking a mid-level Quality Control Analyst to provide fully onsite support for a capital project at a pharmaceutical manufacturing facility in Lexington, Massachusetts.

The QC Analyst will support qualification and implementation of new QC instruments (titrators, density meter, UV spectrophotometers), method transfer and validation, SOP development, analyst training, and GMP documentation. Hands-on GMP lab experience and strong communication skills are preferred.

Qualifications

• Bachelor degree in Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field preferred.
• Experience in a QC lab within pharma/biotech or life sciences.
• GMP-regulated environment experience is required or beneficial.
• Hands-on experience with analytical laboratory instruments and testing procedures.
• Experience authoring or revising SOPs and analytical methods.
• Understanding of analytical method validation and method transfer principles.

Responsibilities

• Support qualification and implementation of new QC lab instruments.
• Provide assay support for new titrators and a density meter.
• Support upgrades and qualification activities for UV spectrophotometers.
• Assist with analytical method transfers for new or updated equipment.
• Author, revise, and review SOPs and analytical methods.
• Execute or support analytical method validation activities.
• Perform analytical testing per approved procedures and GMP requirements.
• Prepare, review, and maintain laboratory and qualification documentation.
• Help develop training materials for QC personnel.
• Train analysts on new instruments and methods.
• Ensure qualification, validation, testing and training are properly documented.
• Collaborate with QC, QA, engineering, validation and project stakeholders.

Skills

QC Laboratory

GMP Compliance

Analytical Instruments

SOP Development

Cross-functional teamwork

Education

Bachelor’s degree in a related scientific field

Tools

Titrators

Density meter

UV spectrophotometers

Job description

Arcadis is seeking a mid-level Quality Control Analyst to provide fully onsite support for a capital project at a pharmaceutical manufacturing facility in Lexington, Massachusetts.

The Quality Control Analyst will support the qualification and implementation of new QC laboratory instruments, including titrators, a density meter, and upgraded UV spectrophotometers. The role will also assist with analytical method transfer, method validation, assay execution, SOP development, analyst training, and associated GMP documentation. This position is best suited for a hands-on QC professional with experience supporting laboratory instrumentation and analytical methods within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

• Support the qualification and implementation of new QC laboratory instruments.
• Provide qualification and assay support for new titrators and a density meter.
• Support upgrades and qualification activities involving UV spectrophotometers.
• Assist with analytical method transfers for newly installed or upgraded laboratory equipment.
• Author, revise, and review Standard Operating Procedures and analytical methods.
• Execute or support analytical method validation activities.
• Perform analytical testing in accordance with approved procedures and GMP requirements.
• Prepare, review, and maintain accurate laboratory and qualification documentation.
• Support the development of training materials for QC laboratory personnel.
• Train analysts on new instruments, analytical methods, and applicable procedures.
• Ensure qualification, validation, testing, and training activities are appropriately documented.
• Collaborate with Quality Control, Quality Assurance, engineering, validation, and project stakeholders.
• Support project milestones and help ensure laboratory instruments and associated methods are ready for routine QC use.
• Identify and communicate technical issues, documentation gaps, or project risks to the appropriate stakeholders.

Qualifications & Experience:

• Bachelor’s degree in Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline. (preferred but not requred)
• Professional experience working in a Quality Control laboratory within the pharmaceutical, biotechnology, or life sciences industry.
• Experience working in a GMP-regulated environment.
• Hands-on experience with analytical laboratory instruments and testing procedures.
• Experience authoring or revising SOPs and analytical methods.
• Understanding of analytical method validation and method transfer principles.
• Experience completing accurate, traceable, and compliant GMP documentation.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating with cross-functional project teams.