Quality Assurance Associate, Wareham, Massachusetts, 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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Quality Assurance Associate, Wareham, Massachusetts, United States

Posted: 07 March 2018

Job Summary
Position is responsible for conducting protocol review inspections, in-life inspections, data and report audits to assess compliance with pertinent GLPs/GMPs and ensure study integrity, protocols and SOPs, as assigned in addition to specialized assignments as designated. 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/GMPs 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, EMEA, FDA GMP and GLP and EPA GLP, as well as industry standards including ICH and FDA guidance standards, and a background in either chemistry or biology.

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/GMPs and/or other regulations effecting work.  Level of proficiency and understanding should allow Associate to train others.

What makes Smithers Viscient a great place to work? Learn about how we make a global impact, and see an overview of employee benefits and perks.

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