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.