QC Reviewer (BSD)

Altasciences Company; Laval; On-site; CAD 60,000 - 90,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Training & Development Programs

Employee Referral Bonus Program

Annual Performance Review

Job summary

Altasciences in Laval, QC is seeking a QC Reviewer (BSD) to perform quality control for data generated in the laboratory and ensure batch documentation meets SOPs and GLP standards.

The role involves drafting study documents, performing multi-batch trend analyses, and mentoring analysts while maintaining timelines and safety guidelines in a regulated bioanalytical environment. Strong organizational, communication, and cross-functional collaboration skills are essential.

Qualifications

• College degree and/or University degree in Chemistry, Biochemistry or Immunology or equivalent field.
• Experience in the medical and/or pharmaceutical fields with typically 3 years of experience in data review and quality control.
• Must understand general SOPs and have knowledge of GLP regulations.
• Proven organizational skills.
• Excellent attention to details with respect to sample preparation procedures and raw data handling.
• Strong communication and leadership skills.
• Ability to work cross functionally.
• Good MS Office skills.

Responsibilities

• Perform QC for data generated and work conducted in the laboratory.
• Ensure batch related documentation is completed accurately and in a timely manner per SOPs.
• Draft study documents for BPI review (Memo to File, SOP/Protocol/Study Plan deviations) and perform multi-batch trend analysis.
• Provide reports/final results within study timelines and reflect deviations or events.
• Daily in-process quality control for batches in the lab.
• Raise flags to line manager regarding quality issues or trends.
• Support responses to QA reports and monitor lab quality per GLP and SOPs.
• Mentor analysts in daily lab documentation procedures and processes.
• Participate in basic training of laboratory staff.
• Ensure verification of laboratory instruments per internal procedures.
• Harmonize techniques, processes and documentation between analysts.
• Participate in laboratory inspections and report deviations and health/safety concerns.
• Assist in planning sample analysis by maintaining timeline and scheduling commitments.
• Stay updated on new SOPs and procedures via training and team meetings.

Skills

MS Office

Cross-functional collaboration

Organizational skills

Attention to detail

Communication skills

Leadership skills

SOP knowledge

GLP regulations understanding

Education

College/University degree in Chemistry/Biochemistry/Immunology

Tools

MS Office

Job description

About The Role

The QC Reviewer (BSD) is responsible to perform the quality control for data generated and work conducted in the laboratory.

What You'll Do Here

• Ensures that all batch related documentation is completed accurately and in a timely manner by the analysts and that all procedures are respected as per the company's SOPs.
• Based on training QC reviewer can draft study documents for BPI review such as Memo to File, SOP/Protocol/Study Plan deviations., perform quality control batch review by performing multi-batch trend analysis, and compile study documentation,
• Based on training, provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate for the review of the Bioanalytical Principal Investigator .
• Based on training, responsible for daily in process quality control for batches ongoing in the lab.
• Raises any flags to line manager regarding any quality issue or trends observed and is part of addressing these issues in an appropriate manner.
• Supports responses to QA reports.
• Monitors the quality within the laboratory according to GLP, regulatory agencies requirements and internal SOPs.
• Supports and mentors analysts in the daily laboratory documentation procedures and processes.
• Can participate in basic training of laboratory staff.
• Could be assigned to ensure that the verification of laboratory instruments is performed as required by the internal procedures.
• Could be assigned to ensure harmonization of techniques, process and documentation between analysts in the laboratory.
• May be required to participate in laboratory inspections: executes and reports deviations and any health and safety concerns.
• As assigned, assist for planning sample analysis by maintaining timeline and scheduling commitments.
• Stays up to date on new SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues and observes all company guidelines and policies.
• Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures.

What You'll Need to Succeed

• College degree and/or University degree in Chemistry, Biochemistry or Immunology or equivalent field.
• Pertinent experience may be considered in lieu.
• Experience in the medical and/or pharmaceutical fields with typically 3 years of experience in data review and quality control field.
• Must understand general SOPs and have knowledge of GLP regulations.
• Proven organizational skills
• Excellent attention to details with respect to sample preparation procedures and raw data handling.
• Strong communication and leadership skills.
• Ability to work cross functionally.
• Good MS Office skills.

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 QC Reviewer (BSD ) in particular, but without limitation, for the following reason(s): The requirement to have study protocols read 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

Altasciences' Incentive Programs Include

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