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Senior Quality Assurance Scientist

2 months ago

Sioux Falls, South Dakota, United States Insight Recruitment Full time

We are looking for a dedicated and experienced Senior Quality Assurance Scientist to contribute to our innovative projects at Insight Recruitment, a prominent biopharmaceutical organization. This position is perfect for a candidate with a robust foundation in Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP), coupled with significant expertise in the development, optimization, qualification, and validation of analytical methods.

As a Senior Quality Assurance Scientist, you will engage with a diverse array of projects, utilizing a variety of techniques in a company that is at the forefront of scientific advancement. Your role will be pivotal in upholding the highest standards of quality and innovation as we progress towards commercialization.

Key Responsibilities:

  • Oversee the creation and validation of intricate bioanalytical methods, including but not limited to ELISA, receptor binding, cell-based assays, immunoassays, bioassays, and ligand binding assays.
  • Communicate findings effectively within departmental and cross-functional teams, contributing to bioanalytical sections for regulatory submissions and scientific publications.
  • Assess and modify specifications based on stability evaluations.
  • Conduct various scientific tasks proficiently, including physical property characterization assays, HPLC, ELISA, PCR, gel electrophoresis, cell culture, and aseptic techniques.
  • Operate effectively under GLP and/or cGMP conditions, ensuring compliant documentation of scientific activities.
  • Assist in the development of analytical methods and laboratory systems, collaborating with technical support, contract manufacturing organizations, and analytical consultants.
  • Draft and update standard operating procedures (SOPs), data records, study protocols, and reports.
  • Support the overall operations of the Quality Control Laboratory.
  • Participate in routine cleaning and maintenance of laboratory facilities.
  • Assist in the upkeep and cleaning of laboratory equipment.
  • Contribute to the training and development of junior staff in various laboratory techniques.
  • Guide junior associates in assay development and laboratory methodologies.
  • Collaborate with external partners and vendors on assay development initiatives.
  • Perform additional duties as assigned by the supervisor.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty satisfactorily. The following qualifications are required:

  • Master's degree with a minimum of 3 years of relevant experience, or
  • Bachelor's degree with at least 5 years of relevant experience.
  • Proven experience in an aseptic laboratory environment.
  • Extensive background working under GLP or GMP regulations.