- Shift / Schedule: 4 x 10-hour shifts — Tuesday-Friday, 10:00 PM - 8:00 AM (Night Shift)
- Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Associate Quality Control - Night Shift
Location: West Greenwich, RI
Onsite Flexibility: Onsite
Contract Details
- Position Type: Contract
- Contract Duration: 12 months
- Pay Rate: $30.00-$38.00 / Hour (USD)
- Shift / Schedule: 4 x 10-hour shifts — Tuesday-Friday, 10:00 PM - 8:00 AM (Night Shift)
- Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Job Summary
Quality Control is searching for an analyst (Associate QC) to support routine testing for the QC Night Shift Team D (Tuesday-Friday from 10 PM - 8 AM) 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.
Key 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
- Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with safety guidelines, cGMP (Good Manufacturing Practices) practices, and other applicable regulations
- Generates complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
- Operates laboratory equipment and instrumentation
- Performs review and approval of assays, documents, and records
- Supports troubleshooting and problem solving
- Alerts management of quality, compliance, supply, and safety risks
- Supports TRAs and deviations, as applicable
- Completes required assigned training to permit execution of required tasks
- Performs routine laboratory procedures
- Performs routine analytical testing
- Documents, computes, compiles, interprets, and enters data
- Maintains and operates specialized equipment
- Initiates and/or implements changes in controlled documents
- Must learn and comply with safety guidelines and cGMPs/CFRs, which include, but are not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems, and laboratory logbooks
- Performs additional duties as specified by management
Required Skills
- 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)
- Must have focus on data integrity
- Commitment of a 40-hour work week (4 x 10-hour shifts) in West Greenwich, RI
Preferred Skills
- 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 biopharmaceuticals process 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 is preferred
Education Requirements
- 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 Experience
- Experience with analytical laboratory testing with the ability to plan and perform routine tasks with efficiency and accuracy
- Qualified to work in the U.S. without employer sponsorship
Nice-to-Have Experience
- 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
- Demonstrated experience in investigations and QC processes
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
Important Notes
- 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. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number: 26-18355 Industry: Manufacturing & Operations
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