QC Analyst III - Portsmouth, NH

About the role

We are seeking a skilled Quality Control Technical Transfer Analyst III to join our team in Portsmouth, NH.

Key Responsibilities

• Execute test samples for In-Process, Lot Release, and Stability studies.
• Perform testing for investigations, technical transfers, and validations.
• Support projects involving method transfers, new instrument implementation, and method qualifications.
• Review assays and data to ensure accuracy and compliance.
• Write and manage Quality Records, including Deviations, CAPAs, and Change Controls.
• Draft and review Test Methods and validation documents.
• Apply Data Integrity principles in all aspects of work, strictly adhering to internal DI policies and guidelines.
• Perform technical root-cause analysis for software errors and deviations.
• Execute software validations, including writing GMP procedures and executing test scripts.
• Act as a Subject Matter Expert (SME) for at least one lab software system.

Qualifications & Requirements

• Education: Associate’s Degree in Microbiology, Biochemistry, or related Science field required.
• Experience: Proven GMP experience within the pharmaceutical industry.
• Software Proficiency: Experience with or current use of SoftmaxPro, Empower, or SoloVPE is highly required. Familiarity with TrackWise and LIMS is a plus.
• Skills & Competencies: Strong ability to write complex quality records and test methods. Excellent verbal and written communication skills; ability to speak publicly and interpret data for cross-functional teams. Ability to interpret data independently, prioritize tasks, and exercise judgment within defined procedures. Self-motivated team player with a positive attitude, commitment to quality, and excellent time management/punctuality.