QC Specialist II

Job Description:

The Quality Control Technical Transfer Analyst 3 supports the QC department by performing analytical testing, assisting with technical transfer activities, and maintaining quality documentation in a GMP-regulated pharmaceutical or biotechnology environment. The role involves executing laboratory testing, reviewing data, supporting validations and investigations, and ensuring compliance with GMP and Data Integrity requirements.

Roles and Responsibilities:

Perform analytical testing for in-process samples, lot release, and stability studies. Support technical transfers, method validations, and laboratory investigations. Review analytical data and ensure results meet quality and compliance standards. Prepare and maintain quality documentation such as Deviations, CAPA, Change Control, and Investigations. Use laboratory systems and software including SoftmaxPro, Empower, SoloVPE, LIMS, and TrackWise. Support software validation activities, including writing procedures and executing validation test scripts. Apply GMP and Data Integrity principles in all laboratory activities. Collaborate with cross-functional teams and provide training when required. Perform root cause analysis for laboratory or software-related issues.

Requirements:

3 5 years of experience in a Quality Control laboratory within the pharmaceutical or biotechnology industry. Experience working in a GMP-regulated environment. Hands-on experience with analytical testing, method transfers, validations, and investigations. Experience with quality systems such as Deviations, CAPA, Change Control, and LIMS/TrackWise is preferred. Associate's Degree in Microbiology, Biochemistry, Biotechnology, Chemistry, or a related Life Sciences field.