Senior Quality Assurance Associate
2 weeks ago
Senior Quality Assurance Associate - Canada #24-POS00029367
{{jcity}}{{jstate}}
Job Description
Senior Quality Assurance Associate
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness, and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently searching for a Senior Quality Assurance Associate reporting to Head, Quality Assurance, Established Mid-Sized Markets Canada.
Description:
- Responsible for auditing batch documents and laboratory test results.
- Responsible for requesting samples for testing and for reserve inventory, and for product release according to Canadian GMP.
- Responsible for handling customer complaints and return goods procedures.
- Responsible for revision of SOPs.
- Responsible for conducting some external site audits.
- Initiates and co-ordinates laboratory testing; audits and prepares batch document from third party manufacturing facilities, approves and releases products.
- Requests samples for QC testing and Retention.
- Documents and responds to customer complaints, processes product returns and determines return goods status.
- Maintains and updates all SOP records.
- Writes reviews and facilitates SOP revisions.
- Conducts GMP inspections of Canadian sites as required.
- Participates in auditing of manufacturing locations if required.
- Reviews validation summaries from manufacturers.
- Discusses with line manager any potential issues related to the QA function and proposes possible solutions and appropriate corrective action plans.
- Provides QA function for clinical supplies release for studies in Canada.
- Manage Method Transfer activities.
- Initiates deviation reports and conducts investigations as necessary.
- Participates in monthly complaint reconciliation meetings.
- Manages the change controls for assigned products.
- Performs other duties as assigned.
*This position will be hybrid, spending 50% in office with 50% of time working from home*
Quantitative Dimensions:
- Timely release of products.
- Assisting with maintaining GMP Compliance.
Organizational Context:
- Reports to Head, Quality Assurance, Established Mid-Sized Markets & Canada
- Interacts with AUST colleagues.
Requirements
Required Qualifications:
- B.Sc. degree in chemistry, microbiology, or life science.
- 3-4 years relevant work experience in the pharmaceutical industry.
- Thorough knowledge of GMP regulations and testing technology in chemistry and microbiology.
- Excellent written and verbal communication skills are required, including French as asset.
- Meticulous attention to detail.
- Proficient in Microsoft Office, SAP and Trackwise
Additional Information
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.
#J-18808-Ljbffr-
Senior Quality Assurance Associate
1 month ago
Markham, Canada Astellas Pharma Full timeSenior Quality Assurance Associate - Canada #24-POS00029367 {{jcity}}{{jstate}} Job Description Senior Quality Assurance Associate At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us...
-
Senior Quality Assurance Associate
1 month ago
Markham, Canada Astellas Pharma Full timeSenior Quality Assurance Associate - Canada #24-POS00029367 {{jcity}}{{jstate}} Job Description Senior Quality Assurance Associate At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us...
-
Senior Quality Assurance Associate
1 month ago
Markham, Canada Astellas Pharma Full timeSenior Quality Assurance Associate - Canada #24-POS00029367 {{jcity}}{{jstate}} Job Description Senior Quality Assurance Associate At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us...
-
Senior Quality Assurance Associate
1 month ago
Markham, Canada Astellas Full timeSenior Quality Assurance Associate Astellas Canada – People Operations PartnerAt Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our...
-
Senior Quality Assurance Associate
1 month ago
Markham, Canada Astellas Pharma Inc. Full timeJob Description Senior Quality Assurance AssociateAstellas Canada – People Operations PartnerAt Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering...
-
Senior Quality Assurance Associate
1 month ago
Markham, ON, Canada Astellas Pharma Full timeSenior Quality Assurance Associate - Canada #24-POS00029367 {{jcity}}{{jstate}} Job Description Senior Quality Assurance Associate At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is...
-
Quality Assurance Specialist
1 month ago
Markham, Canada Shields Pharma Inc. Full timeShields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham, Ontario: **Quality Assurance Specialists** **Reports To: Manager of Quality** Outstanding opportunity for Quality Assurance professionals to join our company based in Markham as...
-
Food Safety and Quality Assurance Associate
4 weeks ago
Markham, Canada Lafayette Sweets Full timeFounded in 1998, Lafayette Group of Companies is headquartered in the Canadian High Tech Center in Markham, Toronto. “Lafayette” is a multinational company in both North America and Asia that manufacturing, processing and distributing baking products and providing technical support for various companies such as airlines, hotels, cafes, retail and grocery...
-
Quality Assurance Manager
1 month ago
Markham, Canada Shields Pharma Inc. Full timeShields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham: **Quality Assurance Manager** **Overall Responsibilities**: QA Manager will perform activities to assure compliance with applicable regulatory requirements by conducting audits,...
-
Quality Assurance Manager
1 month ago
Markham, Canada Shields Pharma Inc. Full timeShields Pharma Inc. is looking for qualified and experienced employees to join the successful team. We currently have the following full time positions available for Markham: **Quality Assurance Manager** **Overall Responsibilities**: QA Manager will perform activities to assure compliance with applicable regulatory requirements by conducting audits,...
-
Markham, ON, Canada Astellas Pharma Full timeSenior Quality Assurance Associate - Canada #24-POS00029367 {{Senior Quality Assurance Associate At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our...
-
Quality Assurance Specialist
1 month ago
Markham, Canada SGS Full timeCompany Description We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world. **Job Description**: - Review and...
-
Quality Assurance Technician
2 days ago
Markham, Canada Taste of Nature Foods Inc. Full time**Job description** Glad to meet you. We are Taste of Nature Foods Inc. (TONFI), working hard to bring healthy snacks to the masses. Proudly Canadian, our company has blossomed over the last 30 years developing healthy snacks for our primary brand, Taste of Nature, sold in over thirty countries around the globe, as well as our significant private label and...
-
Finance Manager, Quality Assurance
4 weeks ago
Markham, Canada Aviva plc Full timeFinance Manager, Quality Assurance page is loaded Finance Manager, Quality Assurance Apply locations Markham posted on Posted 30+ Days Ago job requisition id R-139047 Individually we are people, but together we are Aviva. Individually these are just words, but together they are our Values – Care, Commitment, Community, and...
-
Finance Manager, Quality Assurance
4 weeks ago
Markham, Canada Aviva plc Full timeFinance Manager, Quality Assurance page is loaded Finance Manager, Quality Assurance Apply locations Markham posted on Posted 30+ Days Ago job requisition id R-139047 Individually we are people, but together we are Aviva. Individually these are just words, but together they are our Values – Care, Commitment, Community, and...
-
Finance Manager, Quality Assurance
4 weeks ago
Markham, Canada Aviva plc Full timeFinance Manager, Quality Assurance page is loaded Finance Manager, Quality Assurance Apply locations Markham posted on Posted 30+ Days Ago job requisition id R-139047 Individually we are people, but together we are Aviva. Individually these are just words, but together they are our Values – Care, Commitment, Community, and...
-
Finance Manager, Quality Assurance
1 month ago
Markham, Canada Aviva Full timeIndividually we are people, but together we are Aviva. Individually these are just words, but together they are our Values – Care, Commitment, Community, and Confidence. We are looking for a Finance Manager, Quality Assurance to be responsible for ensuring Aviva Canada Finance maintains strong quality assurance and effective finance operation controls...
-
Underwriting Quality Assurance Specialist
2 weeks ago
Markham, Canada Aviva Full timeIndividually we are people, but together we are Aviva. Individually these are just words, but together they are our Values - Care, Commitment, Community, and Confidence. We have an outstanding career opportunity within our Personal Insurance Quality Assurance team. You will be joining a fast-paced, high-energy team where your work makes a powerful...
-
Associate, Quality Assurance, 12 Month Contract
7 hours ago
Markham, Canada ABBVIE Full timeJoining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 92% of our employees are proud to say they work for AbbVie. When choosing your...
-
Quality Assurance Coordinator
4 weeks ago
Markham, Canada Aurora Cannabis Full time**Coordinator, Quality Assurance** **Job location: Markham, ON** **Employment type: Full Time Employment** **Hours: 40 Hours per week** **A little about us** Hi, we’re Aurora Cannabis, and we’re so excited to meet you! We’re a global cannabis company driven by our passion to help people improve their lives. We have a diverse team who bring their...