QC Specialist II

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

• 35 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.

Pay

N/A

Schedule

N/A

Benefits

N/A