Quality Control Specialist

Title: QC Specialist II
Location: Portsmouth, NH
Pay: $25-31/hr
Contract: 12+ months 

A premier global pharmaceutical organization is seeking an experienced Quality Control Technical Transfer Analyst 3 to join a high-performing QC laboratory team. In this role, you will drive key technical transfer initiatives, perform critical assay reviews, and execute testing for lot releases and stability studies. If you thrive in a collaborative environment where attention to data integrity and routine-to-complex analytical problem-solving directly impacts product quality, this opportunity is ideal for you.

Responsibilities:

• Execute assay reviews, method transfers, and testing for in-process, lot release, and stability studies.
• Support non-routine investigations, method qualifications, and software/instrument validation projects.
• Generate and manage quality records including Deviations, CAPAs, Change Controls, and test methods.
• Act as a Subject Matter Expert (SME) for laboratory software systems and perform technical root-cause analysis for software errors.
• Train cross-functional laboratory personnel and effectively communicate project needs and priorities.
• Maintain strict adherence to Data Integrity principles, GMP compliance, and standard operating procedures.

Required Qualifications:

• Associate’s degree in Microbiology, Biochemistry, or a related scientific field.
• Proven experience managing Quality Records (Deviations, CAPAs, Change Controls, EICRs) and writing test methods.
• Practical knowledge of GMP Quality Systems (e.g., TrackWise, LIMS) and laboratory software suites.
• Strong written, verbal communication, and data interpretation skills.

Preferred Qualifications:

• Direct experience with specialized software such as SoftmaxPro, Empower, or SoloVPE.
• Demonstrated background in writing software validation documents and executing test scripts within a pharmaceutical GMP setting.