Great hybrid 12 month contract opportunity for an experienced QC Analyst who has supported or led QC Lab systems introductions or upgrades. The ideal candidate will have laboratory experience in biopharma and familiarity with lab software applications in particular use of an ELN(electronic notebook) and validation testing of GxP software.
The candidate will execute deliverables for a project to implement the company's new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.
This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).
This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.
This position will work in a team environment, collaborating with various colleagues in the network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.
Key Responsibilities:
- Participate in process engineering activities
- Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflow
- Participate in system requirement, software configuration, and design activities
- Receive and/or verify master data for the site(s)
- Coordinate ELN Template development and review with site SMEs
- Support the development and review of Operational Qualifications
- Execute User Acceptance Testing & Data Migration Verification
- Review and provide input on training materials
- 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.