Quality Assurance Associate 1 (Complaints)

General information

Reference

Position description

Category

Quality / HSE - Quality Assurance

Job Title

Quality Assurance Associate 1 (Complaints)

Company Details

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.


Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.


We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.

We have an opportunity for a Quality Assurance Associate 1 (Complaints).

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.  The QA Associate I is responsible to process complaint samples, perform quality investigations, and monitor and facilitate the closure of open product quality complaints.

Responsibilities

PRIMARY DUTIES AND RESPONSIBILITIES:

• Process customer complaints including sample handling.  Ensure samples are received and analyzed according to procedure in support of complaint investigations.
• Perform quality investigations into product quality complaints to determine root cause and corrective/preventive actions.  Work with the relevant internal departments (i.e., Production, Technical Services, Validation) to gather information related to complaint investigations.
  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 Values, policies, and current standard business practices.

Qualifications

Education

• University degree in a science-related discipline.

Experience

• Three (3) years of quality experience.
• 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.

What we offer: 

• Excellent compensation/benefits package.
• Bonus and reward programs.
• Discounted gym memberships.
• Programs supporting work life balance. 
• Employee recognition program. 
• Professional and personal development programs.
• Social events and spirit days.

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. 
 
Recruitment Fraud – Please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money  
or any personal information up front. We will only respond to official applications submitted through our careers site.  In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider. 
 
Internal Job Posting Grade 8. The due date for internal applicants to apply for this role is 23-June-2025. 

Contract type

Permanent

Candidate criteria

Minimum level of education required

2- College

Minimum level of experience required

2-5 years

Position location

Job location

North America, Canada, Cambridge

Location

Cambridge