Job Description
We are seeking an experienced QC Analyst to support the implementation of our new Electronic Lab Notebook (ELN) system.
About the Role
This is a 12-month contract opportunity for a skilled professional who has experience in biopharma laboratory settings and familiarity with lab software applications, particularly electronic notebooks and GxP software validation testing.
Key Responsibilities:
* Participate in process engineering activities to design, configure, and validate the new ELN system.
* Facilitate the development of new business Standard Operating Procedures (SOPs), forms, and manuals using new processes and workflows.
* Collaborate with colleagues to ensure project commitments are met and participate in system requirements, software configuration, and design activities.
* Receive and/or verify master data for the site(s) and coordinate ELN Template development and review with site SMEs.
* Support the development and review of Operational Qualifications and execute User Acceptance Testing & Data Migration Verification.
* Review and provide input on training materials and support training material development by providing inputs and reviews.
* Support site Instrument Qualification activities such as planning and execution.
Qualifications & Experience:
* Bachelor's degree and 3 years of industry Quality Control experience.
* GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
* Experience in development and validation testing of software used in a GMP environment.
* Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
* Experience in the use of other industry systems such as Veeva & Empower.
* Experience in testing or with processes involving analytical methods.
* Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
* Excellent problem-solving capabilities and attention to detail.
* Experience of collaboration within and across functional areas.
* Excellent written and verbal communication skills.