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location: Somerset, New Jersey
job type: Temporary
salary: $30 - 36 per hour
work hours: 9 to 5
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.
- 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.
- 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.