Quality Assurance Specialist Ii
1 week ago
**Certara is hiring a Quality Assurance Specialist to join our Integrated Drug Development team**
**At Certara, we accelerate medicines to patients by partnering with life science innovators.**
- informed decision-making & reduced clinical trial burden
- higher R&D productivity
- improved patient outcomes & increased patient access to medicines
- accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
**Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.**
The Quality Assurance Specialist is responsible for supporting the quality assurance needs of Certara and specifically integrated Drug Development (iDD), ensuring compliance internally, and externally with customers/clients and regulatory agencies. This position is also responsible for assisting in global corporate quality assurance initiatives and projects as they relate to the implementation and maintenance of quality systems.
**Responsibilities**:
- Proactively identifying and assisting with mitigating quality issues through an increase in process and facility audits to resolve recurring findings and/or client complaints, sometimes resulting in reanalysis of data and/or report updates;
- Increasing the quality culture in IDD by improving the training program through different delivery methods other than SOP reading, such as on-demand training videos and providing instructor-led training during on boarding to allow personnel to meet QA, understand our role, and emphasize quality expectations;
- Assisting the newly formed Clinical Pharmacology Team in the creation of new SOPs. This new initiative will also require active QA engagement when evaluating CROs, Principal Investigators, and clinical test sites for clients, as well as QA reviews of protocols and other deliverables for clients;
- Clinical experience in addition to pre-clinical experience
**Education**:
Bachelor’s Degree preferably in a life sciences or related discipline;
**Experience**:
- 1-2 years of experience in a Quality Assurance role in a GxP regulated environment;
- Detail oriented with effective communication skills (verbal and written);
- Ability to work independently and work with limited direction;
- Ability to interact effectively in a team based environment and with management
- Familiarity with data integrity guidelines;
- Familiarity with bioanalysis and pharmacokinetics an asset;
- Familiarity of computer validation and 21 CFR Part 11/Annex 11 requirements an asset;
- Experience with the use of Quality Management Systems (e.g., TrackWise)
- Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law._
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