QC Specialist II

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 procedures, validation documents, and executing test scripts.

• Act as a Subject Matter Expert (SME) for at least one software system and perform root-cause analysis for software errors.

• Apply Data Integrity principles in all aspects of work and stay current with assigned training.

• Communicate with cross-functional teams to interpret priorities and project needs.

• Train team members, participate in problem-solving, and contribute to process improvements.

Skills & Competencies:

• Strong data interpretation, analytical thinking, and problem-solving skills.

• Ability to prioritize tasks, plan projects, and work independently or in teams.

• Strong written, verbal communication, and presentation skills.

• Ability to recognize deviations from accepted practices and work on problems of moderate scope.

Qualifications:

• Associate’s degree in microbiology, Biochemistry, or related science field.

• Experience working in a GMP pharmaceutical environment preferred.