Job Description

Job Title: Quality Control Senior Associate

Location: West Greenwich, RI, 02817

Duration: 1 year (Possibility of Extension)

Type of Job: Hybrid - (Estimated 3 days per week onsite, up to 5 days as needed)

Overview:

This position is responsible for executing deliverables related to the implementation of Amgen's new, fully Electronic Lab Notebook (ELN) system under BPO supervision. It is a non-laboratory testing position focusing on the design, configuration, and validation of the new ELN system, data migration, and deployment of production instances at various sites. The role requires adherence to established procedures (Standard Operating Procedures, Work Instructions) for safety, cGMP, and CFR requirements.

Key Responsibilities:

• Process Engineering Activities: Participate in process engineering tasks to support ELN system implementation.
• Documentation Development: Facilitate the creation of new business SOPs, forms, manuals, and other related documentation using new processes and workflows.
• System Configuration and Design: Participate in system requirements, software configuration, and design activities.
• Master Data Verification: Receive and/or verify master data for the site(s).
• ELN Template Development: Coordinate the development and review of ELN templates with site Subject Matter Experts (SMEs).
• Operational Qualification Support: Support the development and review of Operational Qualifications (OQs).
• User Acceptance Testing (UAT) & Data Migration Verification: Execute UAT and verify data migration processes.
• Training Support: Review and provide input on training materials; support the development of training materials by providing necessary reviews.
• Instrument Qualification Support: Support site instrument qualification activities, including planning and execution.

Ideal Candidate:

• Education: Bachelor's degree with 2+ years of experience in quality control, or equivalent experience.
• Experience: Minimum of 2 years of experience in quality control or a related field, particularly in regulated environments.

Skills:

1. GxP experience, specifically in the testing of biopharmaceuticals.
2. Experience in the development and validation testing of software used in GMP environments.
3. Experience with electronic lab notebook systems (e.g., Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).
4. Experience with other industry systems such as Veeva & Empower.
5. Knowledge of analytical methods and processes.
6. Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
7. Strong problem-solving capabilities and attention to detail.
8. Proven ability to collaborate within and across functional areas.
9. Excellent written and verbal communication skills.

Basic Qualifications:

• Education: High school/GED with 2 years work experience, OR Associates degree with 6 months of work experience, OR Bachelor's degree.

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