QC Scientist I

Job Description

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.

Duties and 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, Sample Manager 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, and 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.
• 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.

Work Environment/Physical Requirements:

• 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.