Senior QC Reviewer, Sample Management

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

The Senior QC Reviewer, Sample Management, is responsible for sample management general activities; supports the quality control review of the documentation related to the Sample Management team.

Performs audits within the team to ensure that quality standards are respected. Assists in reviewing of SOPs pertaining to Sample Management department. Coaching and training of new employees.

What You'll Do Here

• Responsible of all processes within Sample Management Quality department
• Assume supervisory responsibilities during the supervisor’s absence including managing team activities and resolving issues as needed. To coordinate the activities of QC Reviewer I and QC Reviewer II in the absence of supervisor
• Support and assist in reviewing documentation generated by the Sample Management Department (reception, service and disposal/shipment) and follow up with technical staff
• Coordinate tasks to QC Reviewers.
• Maintains and advocates a high level of quality and customer service within the department.
• Keeps up to date with respect to pertinent regulatory developments in the industry.
• Assists in study samples discrepancies by entering information in tracker, update and follow-up with Scientists.
• Assists and coach QC Reviewers in the verification of study sample and study material transactions, in LIMS systems.
• Establish final QC timeline to ensure timely delivery.
• Creates and updates training documents related to Quality. Controls within Sample Management
• Coaching and training new employees within Sample Management for GLP and GDP.
• Implements process improvements.
• Assists investigations and identify root cause.
• Responsible for finding solutions and support day-to-day issues for Quality Control team within Sample Management.
• Participates in KPIs generation.
• Responds to QA citations.
• Collaborate with key stakeholders to organize meetings and gather scientist requirements for complex studies
• To be present at group meetings.
• Writes and reviews memo to files in support of raw data for supplementary information.
• Initiates deviation (DTS) and assist follow-up, ensure closure and determine root cause.
• Generate labels for study samples if required.
• Archiving documentation.
• Conducts all work in compliance with applicable SOPs, GCPs, GLPs, and observes all company guidelines and policies.
• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues.
• Performs other duties as assigned by management.
  
  

What You Need To Succeed

• Diploma of College Studies in Sciences or B.Sc.
• At least 5 years of experience in sample management in medical or pharmaceutical industry
• At least 3 years of experience in Quality Control
• Excellent knowledge of FDA-GLP/GCP and GDP
• Good Communication skills (French and English for all internal and external clients)
• Works well within a team. Good interpersonal skills.
• Leadership skills, detail oriented, ability to multi-task, well organized, customer service focused.
• Strong decision making and problem-solving ability.
• Proficient in Excel, PowerPoint, Word.
• Knowledge of SharePoint Office 365 would be an asset
• Knowledge of Watson LIMS would be an asset
• Able to function with minimal supervision.
• Ability to work in a fast-paced environment
  
  

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
  
  

Altasciences' Incentive Programs Include

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Review
  
  

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!