Quality Control Reviewer

Bausch Health Companies Inc.; Steinbach; On-site; CAD 56,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Employee Assistance Program

Annual bonus plan

RRSP & DPSP

Job summary

Bausch Health Companies Inc. in Steinbach, MB seeks a Quality Control Reviewer to support the review and release of finished products and related documentation. The role involves ensuring data integrity and adherence to cGMP within a manufacturing setting.

The candidate will review lab records, assist with SOPs, and coordinate instrument calibrations, while maintaining compliance with USP/EP requirements and health & safety standards.

Qualifications

• Bachelor of Science degree with a major in Chemistry or College diploma in Chemical Technology.
• Minimum 3-5 years’ related industry experience for technical/scientific data review.

Responsibilities

• Provide support for the review and release of finished products/stability/in-process/raw material samples and instrument PM/calibration work orders to meet quality control schedules.
• Review of lab documentation, method validation documentation and procedures.
• Provide support with other duties as assigned by Supervisor.
• Participate in right the first-time quality control testing data review on various analytical techniques while following strict procedures/guidelines.
• Collect, organize, and review scientific data thoroughly for site/contract lab within required timelines to ensure completion and accuracy and compliance with established procedures and standards by reviewing lab records and/or electronically for qualified instrument software.
• Make decisions regarding the acceptability of analytical data based on the documentation.
• Perform periodic review of lab instrument/computerized systems as per defined procedure and intervals to enhance data integrity.
• Perform review of data electronically through instruments software/LIMS and manually using lab records.
• Assist in developing, writing, and reviewing and revising departmental SOP’s and Standard Test Methods. Assist with interpretation of USP and EP compendial requirements.
• Review of analytical validation data. Review calibrations in the applicable database management.
• Review out-of-specification laboratory investigations and provide support during audits and assist with the development and preparation of technical reports.
• Provide guidance and feedback to lab personnel regarding compliance with good documentation practices.
• Ensure documents and records are meeting current data integrity and regulatory requirements and strictly followed as per defined procedures.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements in a manufacturing environment.
• Working closely with Supervisor, provide strong technical support and daily coordination activities for lab.
• Participate in the area of occupational health, safety, and wellness.

Skills

Analytical thinking

Attention to detail

Communication

Team player

Time management

Education

Bachelor of Science in Chemistry

College diploma in Chemical Technology

Tools

Empower

Lab-X

Chemstation

Microsoft Office

Job description

Job Location: Steinbach, Manitoba, CAN

Job Requisition ID: 15696

Position Details

Job Title Quality Control Reviewer

Department Quality Control

Reports To Title Supervisor, Quality Control

Supervise Direct Reports No

Shift Permanent, Evening (15:30 – 24:00)

Introduction

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

General Responsibilities

Provide support for the review and release of finished products/stability/in-process/raw material samples and instrument PM/calibration work orders to meet quality control schedules. Review of lab documentation, method validation documentation and procedures. Provide support with other duties as assigned by Supervisor.

Key Responsibilities

• Participate in right the first-time quality control testing data review on various analytical techniques while following strict procedures/guidelines.
• Collect, organize, and review scientific data thoroughly for site/contract lab within required timelines to ensure completion and accuracy and compliance with established procedures and standards by reviewing lab records and/or electronically for qualified instrument software. Make decisions regarding the acceptability of analytical data based on the documentation.
• Perform periodic review of lab instrument/computerized systems as per defined procedure and intervals to enhance data integrity.
• Perform review of data electronically through instruments software/LIMS and manually using lab records.
• Assist in developing, writing, and reviewing and revising departmental SOP’s and Standard Test Methods. Assist with interpretation of USP and EP compendial requirements.
• Review of analytical validation data. Review calibrations in the applicable database management.
• Review out-of-specification laboratory investigations and provide support during audits and assist with the development and preparation of technical reports.
• Provide guidance and feedback to lab personnel regarding compliance with good documentation practices.
• Ensure documents and records are meeting current data integrity and regulatory requirements and strictly followed as per defined procedures.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements in a manufacturing environment.
• Working closely with Supervisor, provide strong technical support and daily coordination activities for lab.
• Participate in the area of occupational health, safety, and wellness.

Education & Experience Requirements

• Bachelor of Science degree with a major in Chemistryor College diploma in Chemical Technology
• Minimum 3-5 years’ related industry experience for technical/scientific data review

Technical And Professional Requirements

• Strong knowledge of US Pharmacopoeia (European Pharmacopoeia an assists).
• Working knowledge of Health Canada, FDA, ICH regulations and guidelines that govern the pharmaceutical industry.
• Thorough understanding/experience of analytical testing and laboratory instrumentation and their software (e.g. Empower, Lab-X, Chemstation)
• Understanding of laboratory, computer software programs, including Microsoft Office, is required
• Basic knowledge of statistical and trends
• Strong knowledge of computer software programs (including Microsoft Office).

Core Competencies

• Excellent communication, interpersonal and problem-solving skills
• Self-motivated, positive attitude, attention to detail and a good team player
• Able to work independently with tight deadlines
• Strong analytical thinking and problem-solving skills
• Good team player
• Ability to manage multiple projects/tasks concurrently and effectively.
• Excellent organizational and time management skills

Total Rewards

The range of starting base pay for this role is $55,973- $75,000. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in our annual bonus program plan.

What we have to offer employees at our site:

• Health insurance commences upon start date
• Employee Assistance Program (EAP)
• Employee Recognition Program
• Full-service cafeteria with weekly lunch specials; free coffee and tea
• Free energized parking
• Free electric vehicle parking
• Annual bonus plan
• Employee Stock Purchase Plan (ESPP) for qualifying employees
• Registered Retirement Savings Plan (RRSP & DPSP) for qualifying employees
• Free onsite gym
• Tuition reimbursement
• Years of Service Awards
• Employee Referral Program
• Maternity Leave top-up
• Apprenticeship Leave top-up

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.