Quality Assurance Associate bei Smithers

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. 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, FDA and EPA GLP, and a background in either chemistry or biology.

Job Duties

Essential Functions:

1. Conduct audits of protocols, raw data, reports, and processes to verify compliance with GLP, internal SOPs, and applicable regulatory guidelines (e.g., EPA, FDA, OECD principles).
2. Accurately and concisely report audit findings to laboratory personnel and management.
3. Participate in facility, process, and computer system audits to ensure ongoing compliance and identify areas for improvement.
4. Maintain QA audit schedules, training records, and controlled documents.
5. Communicate effectively (verbal and written) when interacting with staff members.
6. Assist in preparing for and supporting client, sponsor, and regulatory inspections.
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 - 80%

Standing - 10%

Walking - 10%

Reading - 75%

Speaking - 25%

Visual - 100%

Travel – 10%

Laboratory Safety

1. Must be able to understand and follow laboratory safety standards.

Job Specifications

B.S./B.A. in related sciences (Chemistry or Biology) and a minimum of 3 years of experience in a quality role in the GLP laboratory or equivalent. In lieu of a degree, a minimum of 7 years of relevant experience is preferred.

Comprehensive knowledge of GLPs and/or other regulations effecting work. Requires knowledge of OECD, FDA and EPA GLP, and a background in either chemistry or biology.

Level of proficiency and understanding should allow a Quality Assurance Associate to train others.

Must demonstrate basic proficiency of widely used computer programs (e.g. Microsoft Office Suite) as well as demonstrate ability to learn new software applications.

Good writing and math skills required. 

Some travel may be necessary. 

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