Job Details

Payrate: $37.00 - $39.00/hr.

Summary:
This position will, under BPO supervision, execute deliverables for a project to implement Company's new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.
This position willbe 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 Company network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.

Responsibilities:

• Participate in process engineering activities
• Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
• 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

• Bachelor's degree and 2 years of industry Quality Control or Quality experience or Associate's degree and 6 years of industry Quality Control or Quality experience

• GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
• Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
• Advanced proficiency in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
• Experience in the use of other industry systems such as Veeva & Empower.
• Experience in testing or with processes involving analytical methods.
• Excellent problem-solving capabilities and attention to detail.
• Experience of collaboration within and across functional areas.
• Excellent written and verbal communication skills.
• Experience in development and validation testing of software used in a GMP environment.

Pay Transparency: The typical base pay for this role across the U.S. is: $37.00 - $39.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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