QC Specialist II

Company : Karwell Technologies

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:

• Associate's degree in microbiology, Biochemistry, Biotechnology, Chemistry, or a related Life Sciences field.
• 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/Track Wise is preferred.

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