Associate Quality Control - Night Shift

About the role

Quality Control is searching for an analyst (Associate QC) to support routine testing for the QC Night Shift Team D at Amgen Rhode Island. This person will be responsible for working in the Quality analytical laboratory, using GMPs and GDPs to execute analytical testing. Under general supervision, this position will perform routine procedures and testing in support of the HPLC and CE (Capillary Electrophoresis) group.

Location: West Greenwich, RI (onsite). Contract: 12-month contract position. Work authorization: Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Responsibilities

• Performing analytical testing including time-sensitive samples from Manufacturing (Titer / MMV / Mycoplasma / Endotoxin / Bioburden / TOC / Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Protein Concentration via UV/VIS and HPLC, Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot
• Ensuring facilities, equipment, materials, organization, processes, procedures, and products comply with safety guidelines, cGMP practices, and other applicable regulations
• Generating complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Operating laboratory equipment and instrumentation
• Performing review and approval of assays, documents, and records
• Supporting troubleshooting and problem solving
• Alerting management of quality, compliance, supply, and safety risks
• Supporting TRAs and deviations, as applicable
• Completing required assigned training to permit execution of required tasks
• Performing routine laboratory procedures and routine analytical testing
• Documenting, computing, compiling, interpreting, and entering data
• Maintaining and operating specialized equipment
• Initiating and/or implementing changes in controlled documents
• Learning and complying with safety guidelines and cGMPs/CFRs, including maintenance of training records, laboratory documentation, written procedures, building monitoring systems, and laboratory logbooks
• Performing additional duties as specified by management

Requirements

Education

• Bachelor's degree OR
• Associate's degree and 1–2 years of Quality or Analytical Laboratory experience OR
• High school diploma / GED and 3 years of Quality or Analytical Laboratory experience

Required skills & experience

• Ability to work in a fast-paced, GMP environment
• Familiarity with Quality ideology (GDP, GMP, etc.)
• Technical skill in wet chemistry, HPLC, microbiology, USP/EP testing
• Experience with analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy
• Demonstrated ability to work independently and deliver right-first-time results
• Excellent communication skills (written and verbal)
• Focus on data integrity
• Commitment to a 40-hour work week (4 × 10-hour shifts) in West Greenwich, RI
• Qualified to work in the U.S. without employer sponsorship

Preferred qualifications

• 1–3 years of experience in a GMP analytical laboratory
• Experience executing analytical/biological testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories
• Understanding of biopharmaceutical processes and related unit operations
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy
• Independent, self-motivated, organized, able to multi-task in time-sensitive environments
• Demonstrated experience in investigations and QC processes
• Some lab experience

Pay

$30.00–$38.00 per hour (USD)

Schedule

4 × 10-hour shifts, Tuesday–Friday, 10:00 PM – 8:00 AM (Night Shift)

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Additional details

Interview process: Initial phone interview with hiring manager; suitable candidates will then have an on-site interview at ARI.

About GTT: GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. They support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.