Operational Quality Specialist

Socket.dev; Mississauga; Hybrid; CAD 68,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Mental Health Resources

Job summary

Bora Pharmaceuticals in Ontario is hiring an Operational Quality Specialist to support QA across equipment qualification, deviations, batch release, and change control. The role emphasizes root-cause investigations, CAPA implementation, and collaboration with multiple units in a hybrid work setting.

The candidate should have a minimum of 2 years in pharma QA, a science/engineering degree, and knowledge of SAP or similar statistical tools to support quality decisions.

Qualifications

• Experience in Operational Quality Assurance or related role with similar responsibilities.
• Minimum 2 years in Pharma industry.
• Knowledge of regulatory requirements and quality systems.

Responsibilities

• Prepare and implement QA procedures (SOPs) and review as required.
• Investigate complaints and deviations, perform root-cause analysis and assign CAPAs.
• Review IQ/OQ/PQ and process validation reports for readiness.
• Review batch records and release/reject decisions per QA procedures.
• Participate in quality improvement projects and change controls.
• Coordinate changes with business units, suppliers, and customers.
• Support internal audits, host and participate as needed.
• Maintain team/site metrics and assist in inspections.

Skills

Quality Assurance

Investigations

CAPA tracking

GxP knowledge

Education

Bachelor’s degree in science / engineering / related field

Tools

SAP

Statistical software

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Position Status

This is a full-time, permanent position that is currently vacant and approved to be filled as part of our ongoing staffing needs.

General Description

Operational Quality Specialists (OQS) ensure Bora’s products and processes meet established quality standards. They provide quality support to a myriad of areas such as equipment qualification, validation, annual product reviews, deviations, change controls, complaints, Gembas, and batch record review and release. Their key responsibilities are listed but not limited to the following.

Responsibilities

• Prepare and implement quality assurance procedures (such as SOPs) and be responsible forreviewing as required.

• Participate in investigation of complaints, deviations, and product incidents ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs.

• Review documentation related to equipment qualification (IQ/OQ/PQ) and process validation, and preparation/review of reports.

• Review batch records and associated documentation, releasing or rejecting batches as per quality procedure.

• Participate in improvement projects for Quality systems and other special projects and initiatives, including new product introductions, significant changes to equipment/systems, etc.

• Coordinate planned changes initiated by various business units, suppliers, as well as customers and ensure relevant quality procedures are followed.

• Coordinate responses to internal improvement documents as required, such as audit observations, ensuring compliance to recommendations.

• Accountable for team and site metrics.

• Participate in inspections including roles such as hosting, mission control, auditor, auditee, etc.

Experience and Skills

• Experience in Operational Quality Assurance or related role with similar responsibilities; Minimum 2 years in Pharma industry.

Education

Required:

• Bachelor’s degree in science / engineering / related field or equivalent on-the-job experience through years of service.

Preferred:

• College program completion for OQS role.

• Adequate knowledge of regulatory framework and demonstrated ability to make informed decisions.

• Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.

• Experience with statistical software, SAP.

• Strong interpersonal and communication skills.

• Excellent technical report writing and reviewing skills.

• Able to work independently and in a team environment.

Working Conditions

• 37.5-hour work week in a hybrid work environment, with a minimum of three days onsite per week.

• Rotating afternoon shifts approximately every three months.

• Work will be performed in both production and office environments.

Additional Information

In accordance with Ontario’s pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable.

As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications. These tools do not make final hiring decisions. All decisions related to screening, interviewing, and selection are made by our Talent Acquisition and hiring teams.

Compensation Range

$68,000-85,000

Benefits Include:

• - Competitive salary and performance-based incentives
• - Comprehensive health coverage including medical, dental, and vision insurance
• - Retirement savings plans with employer contributions
• - Paid time off and flexible work arrangements
• - Professional development opportunities
• - Employee wellness programs and resources
• - Employee Assistance Program and Mental Health Resources

If you require accommodation during any stage of the application or interview process, or if you’d like to learn more about our accessibility policies, please contact us at [e-mail].