QC Scientist

Title: QC Scientist
Location: Plainville, MA
Duration: 6 Months
Shift Time: Monday to Friday , 1st Shift
Pay: $28 - $32/hr. on W2
 
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.

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

• 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.
• Demonstrate problem-solving skills. Be proactive, accountable, and adaptable to change.
• Work semi-independently with minimal to moderate supervision, ensuring alignment and prioritization with the supervisor/manager.

• Position requires daily laboratory and computer work, near/far and color vision, use of laboratory PPE, frequent use of hands, sitting, standing, bending/stooping, climbing, pushing, reaching, writing, talking, and hearing; ability to lift up to 30 lbs with or without reasonable accommodation.
• Work with biohazardous/infectious materials, dry ice, chemicals, and strong odors (e.g., SporKlenz, bleach).
• Position is designated as essential personnel and may be required to work during inclement weather or other internal or external emergency situations.
• Occasional extended, off-shift, weekend, and holiday hours may be required to meet business needs.