Quality Analyst III

  • location: Somerset, NJ
  • type: Temp to Perm
  • salary: $30 - $36 per hour
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job description

Quality Analyst III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Somerset, New Jersey
job type: Temporary
salary: $30 - 36 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Perform testing/review on incoming materials, in-process and finished products, and stability studies in QC Laboratory.

  • Analytical : Utilize HPGe, HPLC, GC and other required equipment. Responsible for reserves and internal stability studies. Work with MTD and vendors on Reference Standard programs supporting commercial products.
  • Microbiology : Familiar with aseptic technique. Perform bioburden, sterility tests in cleanroom BSCs. Perform Environmental Monitoring using EM Total Particulate/Viable monitors, and other required equipment/materials. Coordinate growth promotion/IDs.
RESPONSIBILITIES

  • Perform routine, non-routine and some advanced QC testing in accordance with SOPs and cGMP guidelines. Perform a wide variety of methods and utilize equipment ranging from basic to advanced. Limited supervision required.
  • Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
  • Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
  • Utilize a range of electronic systems such as document/equipment management software, LIMS, Empower, and ERP.
  • Author and review SOP changes; participate in change controls, CAPAs and other quality systems.
  • Resolve routine and some advanced problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
  • Participate in protocols for procedural and instrumentation validations.
  • Work on special projects as needed. Contribute towards continuous improvement.
  • Train on and maintain considerable knowledge of current regulatory requirements and relevant internal procedures.
  • Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
  • Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
  • Promote and actively demonstrate the values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
 
qualifications:
  • Typically requires 3-5 years with a BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
  • Routinely scheduled work may be required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
  • Work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and must be able to lift/move materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals/waste containers
 
skills: CAPA, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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