QA Auditor

Your New Company
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
Responsible for implementing systematic and independent audit of GLP study-related activities and documents; to determine whether the evaluated study-related activities were conducted in a GLP compliant manner; and to assure that the data were recorded, analyzed, and accurately reported according to the applicable regulatory requirements, protocol, method, and SOPs.

Responsible for building and maintaining effective working relationships  working relationships throughout the organization.

What You'll Do Here

• Audits of nonclinical and laboratory studies (Protocols/Plans, raw data, reports) and performs related duties to ensure GLP regulatory compliance.

• Acts as lead auditor on studies and projects; facilitates planning and implementation.

• Prepares, issues, and tracks reports of findings and recommendations noted during audits; assures findings and recommendations accurately reflect requirements of the regulations, protocol/plan, method, or SOP(s).

• Maintains necessary documentation of QA records and study files.

• Audits equipment qualification and software validations.

• Supports project planning and implementation.

• Identifies compliance gaps in processes, systems, and studies; collaborates with QA management to enact change.

• Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.

• Provides risk-based compliance opinions and guidance.

• Recognizes and supports opportunities for improvements within the department.

• Carries out appropriate self-development efforts as directed.

• Assists with regulatory training of staff. 

What You'll Need to Succeed

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.

• Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment.

• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or other certification is recommended.

• Microsoft Office Suite efficiency

• Good communication skills, detail oriented, well organized, customer service focused, able to work in fast-paced environment.

• Background on Statistics and/or Pharmacokinetics preferred

• Ability to read and interpret documents such as procedures, study records, equipment & software manuals, and safety rules;

• Ability to write clear correspondence and routine reports; ability to speak effectively to employees within the organization and sponsors.

• Ability to utilize appropriate mathematical concepts to independently verify study results.

• Ability to work with minimal supervision; ability to audit most disciplines.

• Ability to interpret a variety of instructions provided in written, oral, diagram, or schedule format.

• Training needs for this position include on-the-job training in performing audits, and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.

Altasciences strives to provide a French work environment for its employees in Quebec. Altasciences has taken all reasonable measures to avoid imposing the above language requirement.

This requirement is essential for the position of the QA Auditor in particular, but without limitation, for the following reason(s):

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

What We Offer   

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans

• 401(k)/RRSP with Employer Match

• Paid Vacation and Holidays

• Paid Sick and Bereavement Leave

• Employee Assistance & Telehealth Programs

• Telework when applicable

Altasciences' Incentive Programs Include:

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Reviews

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences