Altasciences · 3 days ago

Quality Assurance Associate

Scott Township, PA

Full-time

Onsite

Entry Level

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Responsibilities

Audit phases of laboratory and clinical studies to ensure regulatory compliance.

Write and issue inspection reports, working with internal clients to communicate findings.

Identify opportunities for process improvement based on audit observations.

Maintain QA records and study files.

Interpret regulatory documents to facilitate auditing and process improvement recommendations.

Perform other related duties as assigned.

Qualification

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GCPGLPGCLPFrench LanguageEnglish LanguageOrganizedPrioritizationAttention to DetailTime ManagementMultitaskingMeeting DeadlinesTactfulReliablePersuasiveDependableConsistentFlexibleCommunication Skills

Required

Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry.

Basic knowledge and understanding of the applicable Canadian, US, European, and ICH pharmaceutical regulations and guidelines, for preclinical and phase I research studies (i.e., GCP, GLP, and GCLP).

Highly organized; ability to prioritize and demonstrate attention to detail.

Time management skills are required, as well as the ability to handle multiple projects.

Ability to meet tight deadlines.

Tactful, reliable, persuasive, dependable, consistent, flexible.

Good written and oral communication skills in French and English.

Software: Microsoft Office. Knowledge of Master Control, Watson LIMS and Analyst an asset.