Company: Auxilium Health
Location: Oshawa, ON
Expected salary:
Job date: Thu, 16 Jan 2025 04:23:05 GMT
Job description: POSITION: Quality Assurance Associate
COMPANY: Stratum Canada
LOCATION: Oshawa, Ontario
EMPLOYMENT TYPE: Permanent, full time, on-site (remote work is not available at this time)
HOURS WORKED: 37.5/week
DEPARTMENT: Quality Assurance
REPORTING TO: Quality Assurance Manager
DIRECT REPORTS: NoneABOUT US:Stratum Canada is driven by a shared vision to advance specialty pharmaceutical solutions, improve patient outcomes, and make a positive impact on healthcare. Our diversified portfolio of companies under the Stratum Canada corporate umbrella allows us to address various aspects of healthcare delivery and provide comprehensive solutions to patients, healthcare providers, and stakeholders across the industry. To learn more about our company, please visit our website: https://www.stratumcanada.ca/.POSITION SUMMARY:The Quality Assurance Associate will be responsible for monitoring and ensuring compliance with company policies, internal procedures and applicable regulations and assisting in the continued development and improvement of the company’s Quality Management System (QMS).GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS:
- Maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs)
- Oversee distribution of training on SOPs and WIs and follow up with associates as required to ensure on-time completion of training
- Perform investigations associated with non-conformance events, such as Deviations and Complaints
- Perform Vendor Qualification evaluations
- Assist with the initiation, approval and oversight of Change Controls and Corrective and Preventative Actions (CAPAs)
- Assist with the preparation and completion of internal audits and regulatory inspections
- Assist with the preparation of receiving, storage, distribution and recall documentation
- Assist with the monitoring of Key Performance Indicators (KPIs) associated with the QMS
- Assist the Quality Assurance department, as required
- Other duties and projects, as assigned
QUALIFICATIONS:
- Knowledge and understanding of Good Manufacturing Practices (GMP) and Health Canada guidelines for handling, storage, distribution, recall of pharmaceutical and medical device products.
- Experience with SOPs and quality documentation
- Experience with the requirements and elements of a QMS, including experience with quality processes such as Deviations, Complaints, Change Controls, CAPAs and Audits
- Excellent verbal and written communication skills
- Excellent interpersonal skills and attention to details
- Excellent time management skills, with a proven ability to prioritize and meet deadlines
- Strong analytical and problem-solving skills
- Proficient with Microsoft Office Suite or related software
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in a related field (Quality Assurance, Regulatory Affairs, Chemistry)
- 2+ years of experience in a related field (Quality Assurance, Regulatory Affairs, Compliance)
WORKING CONDITIONS:
- Office environment
- Siting and working at a computer several hours of the day
- Ability to work alone or on a team
- Ability to work under minimal supervision
OUR COMMITMENT TO YOU:We are committed to a company culture that motivates collaboration, innovation, and continuous improvement and development. We encourage all employees to share forward-thinking ideas and work at their highest potential.We support the health and wellness of our employees and offer a flex benefits plan covering medical, dental and vision services.We appreciate the applications from all candidates but please note we will only be directly contacting the candidates that are selected for an interview.We are an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.Powered by JazzHR