Business System Analyst - Mississauga - Bora Pharmaceuticals

Description

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.

• A modern and state-of-the-art facility.
• An on-site cafeteria with dedicated chefs.
• On-site gym and basketball court.
• Take a video tour of our Mississauga facility:
• Learn more about Bora Pharmaceuticals: A Future Focused CDMO

POSITION DESCRIPTION

JOB TITLE: Business System Analyst (Labware LIMS)

DEPARTMENT: Quality Control

POSITION REPORTING TO: Supervisor, Analytical Compliance and Support

POSITION STATUS: This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open position.

General Description

• Construct new products/raw materials within the Bora Labware Environment (align the LIMS with the methods and specifications for our products/materials).
• Develop custom Certificate of Analysis profiles as per clients needs.
• Manage changes to any existing products (change implementation and documentation).
• Serve as site LIMS subject matter expert managing system changes and any upgrades.
• Support audit readiness, regulatory inspections, and compliance-driven documentation.
• Provide on-going support to the labs for any Labware related issues that arise.

Responsibilities

Key Responsibilities

• Site Expert of Labware LIMS system.
• Manage LIMS Change Process.
• Manage LIMS Data by providing guidance on best practices, overseeing data maintenance activities including design and verification.
• Perform data maintenance activities to support business needs.
• Facilitate the training of LIMS Users by providing assistance, information, materials or training as required.
• Support users with issues regarding dashboards, alarms and data/trends where required for monthly and PPR trending. Update existing product files where changes are required.
• Verify files and data for addition of new product/stages to the Trending System.
• Support end users of Stability Program on site and troubleshoot issues with Protocols and Batch set downs.
• Support data loading of Stability related methods on Empower by ensuring LIMS Data is compatible.

Qualifications

Education and Skills

• A minimum of 5 years relevant experience within the pharmaceutical industry. Experience with Raw Materials testing is an asset.
• Have a sound technical knowledge of their specific discipline and good understanding of critical business functions on site.
• Have a sound technical knowledge of Quality and IT systems and a good understanding of critical business functions.
• Have "key user" experience in LIMS systems. Labware LIMS strongly preferred.
• Detailed knowledge of the cGMP requirements relevant to the role.
• Have knowledge of auditing principles and practices. Knowledge of pharmaceutical (particularly active ingredients) computer documentation requirements and their control.
• Knowledge of Pharmaceutical Chemistry lab testing and Computers.

Education

Required

• Minimum of a degree in Chemistry with some relevant experience and/or equivalent degree.
• IT literate to the demands of the current data system architecture and electronic communications.

Preferred

• Administrator training from Labware.

Working Conditions

• Standard office environment.
• 37.5 work week, additional overtime hours may be required based on business needs.

Compensation Range

$68,000 - $85,000

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, experience and internal equity. Bora Pharmaceuticals offers a competitive total rewards and benefits package for permanent, full-time positions designed to support our employees' wellbeing, including:

• 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.
• Employee wellness programs and resources.
• Employee Assistance Program and Mental Health Resources.

Our Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. These values drive innovation, strengthen our teams, and ensure that we provide the best services to our employees and clients.

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.

Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Bora is also committed to accommodating persons with disabilities. If you require accommodation at any stage of the recruitment process, please contact us at - Please do not send resumes to this email address. All applications must be submitted through the online application process linked to this posting.

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