Quality Assurance Associate I (Complaints)

Septodont North America; Cambridge; On-site; CAD 55,000 - 70,000; Full time

Job summary

A leading quality assurance firm in the Region of Waterloo is seeking a Quality Assurance Associate I for a 12-month contract. This role involves processing product quality complaints, performing investigations, and preparing reports. Candidates must have a university degree in a science-related discipline and three years of experience in quality assurance. Strong communication skills and attention to detail are essential.

Qualifications

• Three years of quality experience is required.
• Strong verbal and written communication skills are necessary.
• Acute attention to detail is essential.

Responsibilities

• Process customer complaints including sample handling.
• Perform quality investigations into product quality complaints.
• Prepare final complaint reports and customer response letters.

Skills

Strong verbal and written communication skills

Attention to detail

Time management skills

Technical writing skills

Ability to work in a self-directed team environment

Education

University degree in a science-related discipline

Tools

Microsoft Office applications

Job description

Quality Assurance Associate I (Complaints) - 12 Month Contract.

Job Summary

The Quality Assurance Associate I (Complaints) position is accountable to the Senior QA Manager (Product) and is responsible for the processing and handling of product quality complaints including those associated with both dental and pharma related products.

Responsibilities

• Process customer complaints including sample handling.
• Perform quality investigations into product quality complaints to determine root cause and corrective/preventive actions.
• Follow up with complainants to ensure all relevant information is available to perform a thorough investigation.
• Liaise with clients to complete quality investigations in which Novocol is the CDMO (contract and development manufacturing organization).
• Complete quality investigations according to contractual timelines noted in Quality Agreements with clients.
• Prepare final complaint reports and customer response letters.
• Ensure all complaints are investigated and reported in a timely manner as detailed in applicable SOP’s and regulations.
• Assist with Pharmacovigilance related complaints including, but not limited to batch record review and the creation of batch summary reports.
• Perform regular analysis and trending of complaint data, summarizing data in dashboards, trend reports and Annual Product Review reports.
• Track and monitor open complaints and drive site adherence to target dates.
• May perform other related duties as assigned including participation in the internal audit program, tracking and monitoring of open quality events, administrative support for product recalls, 3PL oversight, and the investigation of open quality events as required.
• Follow GMP and regulatory requirements, and ensure quality standards are met.
• Observe and support all safety guidelines and regulations.
• Demonstrate the Company Mission, Vision and Values Statement, policies, and current standard business practices.

Qualifications

Education: University degree in a science-related discipline is required.

Experience

• Three (3) years of quality experience.
• Strong verbal and written communication skills.
• Acute attention to detail.
• Well-developed time management skills and effective technical writing skills.
• Ability to work in a self-directed team environment.
• Familiarity with Microsoft Office applications, especially Excel, Word, and Power Point.

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.