Biologist 1, Snow Camp, North Carolina, United States

 

We are a member company of The Smithers Group, trusted providers of innovative solutions. Smithers Viscient performs environmental and consumer safety contract research and regulatory services for the crop protection, pharmaceutical, industrial chemical, and the consumer product industries. Smithers Viscient has performed standard guideline and higher-tiered environmental studies for over 45 years. We conduct studies to satisfy all regulatory requirements globally. Smithers Viscient is a leader delivering trusted testing services.

Offerings include environmental fate, plant and animal metabolism, aquatic and terrestrial ecotoxicology, honeybee and pollinator testing, avian toxicology, residue, analytical, and product chemistry, and regulatory risk assessment.  Contact us to apply or to learn more about a career at Smithers Viscient. 

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Biologist 1, Snow Camp, North Carolina, United States

Posted: 08 October 2018

Job Summary
 
Position is responsible for conducting protocol review inspections, in-life inspections, data and report audits to assess compliance with pertinent GLPs and ensure study integrity, protocols and SOPs, as assigned in addition to specialized assignments as designated. These activities include avian, aquatic, plants, and field studies conducted under applicable Good Laboratory Practice Standards (GLP).  Performs internal facility audits, develops audit reports, and follows up with management.  Position responsibilities also include maintaining audit logs and assisting in special assignments at the request of the QA Manager/Director.  Position is responsible for providing training in GLPs to operations staff and junior QAU staff. Individual requires a degree of independent activity and creative thought to adapt and develop new programs to meet special needs.  Participates in client audits and facilities inspections.  May be delegated in charge of daily activities in absence of Supervisor.  Good writing and math skills required.  Some travel may be necessary.  Requires knowledge of OECD and EPA GLP, as well as industry standards including ICH and FDA guidance standards, and a background in either chemistry or biology.
 
 

  1. Job Duties
 
Essential Functions:
 
  1. Conduct phase inspections, data and report audits.
  2. Write phase/data/report audits.
  3. Maintain accurate QA files.
  4. Verbal and written interaction with staff members.
  5. Client audits.
  6. Special projects as assigned by Supervisor or Department Manager.
  7. Provide training to operations staff in the areas of quality systems procedures (SOPs) and regulatory compliance
  8. Additional duties as assigned
 
 
Marginal Functions:
 
  1. Review Master Schedule as needed.
  2. Review of computer based training records as needed
  3. Meet with Study Directors to establish inspection schedule.
  4. Assist with new aspects of Quality program as needed.
 
Physical Functions
 
Sitting - 40%
Standing - 30%
Walking - 30%
Reading - 50%
Speaking - 50%
Visual - 100%
Travel – 30%
 
  1. Laboratory Safety
 
  1. Must be able to understand and follow laboratory safety standards.

 
Job Specifications
 
B.S. /B.A. in related sciences and a minimum of 3 years of experience in a quality role in the GLP/GMP laboratory or equivalent. In lieu of a degree, a minimum of 7 years of relevant experience is acceptable. Comprehensive knowledge of GLPs and/or other regulations effecting work.  Must be knowledgeable in applicable GLP/QA activities as they pertain to avian, aquatic, plant, and field studies, including conducting protocol review, phase inspections, data and report audits. Level of proficiency and understanding should allow Associate to train others.
 
Next Position Level – Senior Quality Assurance Associate

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To apply for this position, please send your CV to lobrien@smithers.com