Quality Control Scientist

Integrated Resources, Inc ( IRI ); Plainville (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Integrated Resources, Inc. (IRI) is seeking a Bioanalytical QC Analyst to support cGMP testing in our Massachusetts laboratory.

You will perform QC testing, data review, equipment maintenance, and document control to ensure quality and regulatory compliance. Requirements include a Bachelor's degree in biology or analytical chemistry and 1–3+ years of related industry experience, plus familiarity with TOC, pH, ELISA, UHPLC, and qPCR methods.

Qualifications

• Bachelor's degree in biology, analytical chemistry, or related science.
• 1–3+ years of relevant lab experience in a GxP or bioanalytical setting.
• Experience with QC testing, method transfers, and SOPs.
• Familiarity with cGMP and quality systems; inspection readiness.

Responsibilities

• Perform cGMP QC bioanalytical testing and data review.
• Troubleshoot routine and complex assays (TOC, pH, ELISA, UHPLC, qPCR).
• Assist with method transfers, validations, and QA documentation.
• Maintain equipment, calibration, and reference standards.
• Prepare training materials and contribute to CAPAs/OOS records.
• Support audits and inspections readiness.

Skills

Communication skills

Attention to detail

Problem solving

Team collaboration

English proficiency

Safety awareness

Time management

Adaptability

Education

Bachelor's degree in biology/analytical chemistry

Tools

Empower

LIMS

TrackWise

Smartsheet

MS Office

Job description

Duration: 6+ Months ( Potential Extension)

Shift Time: Monday to Friday , 1st Shift

Job Summary:

In this position within the Quality Control Bioanalytical laboratory team, you will play a key role to support QC testing for our cGMP compliant clinical and commercial grade Manufacturing. Your work directly impacts the quality, safety, and compliance of treatments we help bring to market.

Responsibilities:

• Perform cGMP QC Bioanalytical testing, troubleshooting, laboratory operations, equipment maintenance, data review, training, quality records, method transfer support, and other departmental activities as assigned.
• Perform timely, Right First Time (RFT) cGMP testing and documentation of in-process (including STAT), release, stability, and critical utility (TOC/C) testing while following approved procedures and safe laboratory practices. Troubleshoot routine technical issues.
• Perform and troubleshoot routine and complex testing such as TOC/Conductivity, compendial assays (e.g., appearance, pH, osmolality), FTIR, A260, cell count/viability, Viral Genome Titer (VGT) by ddPCR/qPCR, infectivity assays (e.g., TCID50), icIEF/CE-SDS, SDS-PAGE gels, ELISA, UHPLC, and other laboratory assays.
• Support timely transfer, qualification, validation, verification, and troubleshooting of routine/complex QC methods for clients. Technical lead for compendial verifications.
• Perform/support QC equipment maintenance and calibration activities in coordination with Facilities, Maintenance, Automation, and/or vendors, as applicable. Support new equipment onboarding as assigned.
• Perform data and documentation review to ensure data integrity and compliance.
• Perform routine laboratory operations, including cleaning and organization, stocking materials, reagent preparation, and timely completion and review of logbooks. Support the reference standards and critical reagents program, including applicable inventory management and trending.
• Complete required cGMP and job-specific training in a timely manner. Train others and may develop On-the-Job Training (OJT) materials, as assigned.
• Author and revise technical documents (e.g., SOPs, Work Instructions, Forms) for equipment, methods, and laboratory processes.
• Author and own quality records (e.g., LIRs, Deviations, OOS, and CAPAs), other as needed.
• Support laboratory inspection readiness and participate in audits and inspections, as needed.
• Utilize laboratory software systems (e.g., Empower, SampleManager LIMS); quality management systems (e.g., TrackWise, D2); Microsoft Word, Excel, Outlook, Teams, PowerPoint; Smartsheet; and other systems, as required.
• Participate in continuous improvement initiatives.
• Participate in team meetings. Collaborate effectively with team members and cross-functional partners.
• Identify issues, communicate timely solutions, and lead resolution of routine and complex problems using scientific thinking and sound judgment.
• Apply working knowledge of cGMP Quality Control systems and applicable regulatory requirements.

Education:

• Bachelor's degree in biological (e.g., molecular biology), analytical chemistry, or related science and Client 1–3+ years of relevant industry experience.

Experience:

• Experience as a laboratory analyst/scientist, performing testing and troubleshooting, preferably in a GxP-regulated laboratory (e.g., Quality Control), with routine and complex bioanalytical methods and instrumentation (or similar). Experience with method transfers, and technical document authoring.
• Experience with QC laboratory safety, scientific processes, and cGMP practices. Experience supporting quality systems and inspection readiness.

Knowledge, Skills, Abilities:

• Demonstrate flexibility and the ability to work safely in a fast-paced, dynamic environment, manage multiple priorities, meet internal and external deadlines, and maintain attention to detail.
• Demonstrate effective, professional verbal and written communication, active listening, interpersonal skills, and collaborative workplace behaviors. Read, write, and speak English.
• Be proactive, accountable, and adaptable to change.
• Work semi-independently with minimal to moderate supervision, ensuring alignment and prioritization with the supervisor/manager.