QC Specialist II

Confidential · Portsmouth, New Hampshire, United States

Location
Portsmouth
Job Type
Full-time
Posted
June 30, 2026

Job Description


Job Title: QC Specialist II
Job Location: Portsmouth, NH
Job Duration: months on W

Key Responsibilities:

  • Perform testing for in-process, lot release, stability studies, investigations, transfers, and validations.

  • Review assays and support technical transfer activities.

  • Write and maintain Quality Records, including Deviations, CAPA, Change Control, and test methods.

  • Participate in projects such as method transfers, new instruments, and method qualifications.

  • Use laboratory computer systems and Microsoft Office (Word, Excel, PowerPoint).

  • Utilize GMP Quality Systems such as TrackWise and LIMS.

  • Work with laboratory software including SoftmaxPro, Empower, and SoloVPE.

  • Support software validation activities, including writing GMP ...

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