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Quality Control Senior Associate
Spectraforce
West Greenwich, Rhode Island

2 hours ago

Job Description

Job Title: Quality Control Senior Associate
Location: West Greenwich, Rhode Island
Duration: 12 Months 
Shift: Standard 8-5 local hours


Description:

The role will be on-site based out of Client Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing the following: in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.

Responsibilities include the following:
  • Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
  • Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
  • Operate laboratory equipment and instrumentation
  • Performs review and approval of assays, documents and records
  • Supports Continual Improvement initiatives
  • Alerts management of quality, compliance, supply and safety risks
  • Participate in laboratory investigations
  • Perform general laboratory housekeeping activities
  • Completes required assigned training to permit carry through of required tasks
  • Performs additional duties as specified by management
Basic Qualifications
  • Master's Degree
  • Bachelor's Degree and 2 years of Quality experience
  • Associate's degree and 6 years of Quality experience
  • High school diploma/GED and 8 years of Quality experience

Preferred Qualifications
  • 1-2 years’ experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as: Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing
  • Demonstrated experience in laboratory investigations, method validation, audits, QC processes
  • Proven ability to interpret scientific data
  • Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction

Basic Qualifications    
  • High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors
Top 3 Must Have Skill Sets:    
  • HPLC, General Chem, CE
Day to Day Responsibilities:    
  • GMP Testing, Performs review and approval of assays, Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
  • Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
Possible Extension:    
  • Yes
Red Flags:    
  • No QC past experience
Interview Process:    
  • 1 Stage of interview only | MS Teams.
  • Interview with 2-4 panelist
 
Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.73/hr.

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