QC Stability Coordinator Assistant

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 our world-class sites in North America and Asia we deliver drug products with unparalleled quality to more than 100 markets around the world. Boras 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 customers success more certain.

Position Status

This is a 12-month fixed-term contract (FTC) and a backfill position. The role is an active approved vacancy within the organization and is intended to support current staffing needs.

General Description

Participate in organization and maintenance of the stability program. Work to achieve compliance with global regulatory and customer requirements for stability. Ensure samples are set down and pulled from stability chambers within required testing windows and provide written stability reports to customers.

Key Responsibilities

• Help to create and maintain stability protocols.

• Maintain the stability chamber stability sample inventory and routinely monitor chamber performance.

• Ensure remaining samples from completed stability studies are appropriately disposed as per local procedures.

• Assist in stability data review and trending of results upon completion of timepoint testing.

• Participate in preparation of stability reports according to agreed schedule/due dates for US FDA annual reports Canadian submission and ROW countries.

• Perform stability pulls according to the stability pull-schedule.

• Check production schedules for batches to be set down.

• Ensure that laboratories aware of incoming stability batches for testing and monitor the execution status.

• Labware pull check 3 times every week .

• Preparation of sample for stability study.

• Stability report data check.

Experience & Skills

• 1-3 years of pharmaceutical experience with the knowledge of cGMP ICH and FDA stability guidelines.

• Excellent written and oral communication skills.

• Hands-on lab testing experience is an asset.

• Extensive computer experience including LIMs software SAP Statistical programs MS Word and Excel.

• Experience in the evaluation of analytical data including statistical interpretation of stability data.

• Good overall knowledge of pharmaceutical business operations.

Education

Required:

• College diploma/certificate in Chemistry.

• Computer proficiency for MS Word & MS Excel.

• GMP and GLP experience / knowledge.

Preferred:

• Bachelor of Science degree in Chemistry.

Working Conditions

• Working within chemistry and microbiology laboratories as well as production.

• Combination of desk work and working within the stability chambers.

• Overtime work could be required as per business needs.

• 37.5 hour work week.

• Light lifting.

Additional Information

In accordance with Ontarios 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

$46430 - $58040

Benefits Include:

We offer a comprehensive benefits package 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

-Professional development opportunities

-Employee wellness programs and resources

-Employee Assistance Program and Mental Health Resources

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.
Were proud to be an equal opportunity employer committed to building a diverse and inclusive workplace where everyone feels empowered to contribute and grow. We welcome applications from qualified individuals of all backgrounds experiences and perspectives.

If you require accommodation during any stage of the application or interview process or if youd like to learn more about our accessibility policies please contact us at

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 46430 - 58040