Analyst I, Quality Assurance
7 months ago
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Quality Assurance Analyst I, reports to the Manager of Quality by ensuring the primary objective of batch record review and on the floor activities are effective and in compliance with regulatory requirements
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Batch Record Review
Review all batch documentation in accordance to governing procedures. This includes but is not limited to commercial and clinical manufacturing, Tech Transfer and Engineering runs.
Resolve errors and/or discrepancies in a timely manner and ensure appropriate action is taken.
Escalate any concerns or potential non-conformances to Supervisor and/or Manager
Compile and collate batch documentation packages
Prepare Release Protocols for submission to regulatory agencies
Perform ERP transactions associated with lot release; physically identify lot status
Commercial Product Distribution
Review shipment documentation in accordance to governing procedures. This includes shipments pertaining to commercial (licensed) distribution and excludes all clinical and unlicensed shipments.
Ensure all requirements have been met for QA release of the product shipment. This includes but is not limited to review against applicable Quality Agreements and/or contracts associated with the shipment. In addition, ensuring there are no regulatory restrictions on the product being shipped.
**Other Activities**:
Floor QA activities - monitor production, quality control and other support areas for compliance with procedures and GMP
Support coverage of operational activities outside of core working hours
Act as QA representative on project teams and/or meetings, as required.
Aid in the preparation of Quality Systems reports; this includes but is not limited to providing information on metrics.
Assist in the preparation and collating of information in support of audits and customer/regulatory inspections.
Perform other tasks as assigned.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Minimum
- B.Sc. Degree in Science, Pharmacy, Engineering or relevant college or technical diploma in chemistry/ biology/ biotechnology or High school diploma.
- Minimum
- 2 years GXP related experience in the Pharmaceutical industry.
- The ability to be detail and goal oriented, focused on team work and the customer, prioritize and adapt to business needs as required.
- Excellent written and verbal communication skills are essential in addition to possessing the ability to work collaboratively as a team or independently.
- Capable of receiving detailed instructions on all routine work.
- Ability to perform simple problem solving and data analysis.
-
Quality Assurance Specialist
6 months ago
Winnipeg, Canada Canada Life Assurance Company Full timeQuality Assurance Specialist **Description: - Permanent Full Time- **Position Overview**Accountabilities** - Contributes to the development of the project deliverables, with respect to definition of project scope, estimates for QA tasks, identification of stakeholders, approach, methodology, communication plan, QA resourcing and schedule. - Gains clear...
-
Quality Assurance Analyst
6 months ago
Winnipeg, Canada Payworks Inc. Full timeDoing business to business, person to person. Payworks is a leading workforce management solutions provider and multi-year winner of the Canada’s Best Managed Companies program. We are proud to be Canadian owned and operated as well as committed to developing world-class products and providing a progressive workplace culture where **Doing Right by...
-
Quality Assurance Analyst
6 months ago
Winnipeg, Canada Cabela's and Bass Pro Shops Canada Full time**Summary**: Reporting to the IT Ecommerce Manager, Technology, the Quality Assurance Analyst is responsible for developing and executing software test plans to identify software defects and their causes. They will be responsible for testing activities focused on product functionality, performance, reliability, stability, and compatibility of product lines....
-
Quality Assurance Analyst
7 months ago
Winnipeg, Canada Online Business Systems Full timeWe are looking for a skilled Quality Assurance Analyst to join our Business Consulting team in Winnipeg. With your strong understanding of business and quality assurance processes, you will contribute to projects that leverage technology to deliver business quality and value to our clients. **What you'll do**: - Help develop a comprehensive automation test...
-
Quality Assurance Specialist
2 months ago
Winnipeg, Canada The Canada Life Assurance Company Full timePermanent Full Time We are looking for a **QA Specialist** **Role description** **Position Overview** **What you will do**: - Contributes to the development of the project deliverables, with respect to definition of project scope, estimates for QA tasks, identification of stakeholders, approach, methodology, communication plan, QA resourcing and...
-
Specialist I, Quality Assurance
6 months ago
Winnipeg, Canada Emergent Biosolutions Full timeThose who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. SPECIALIST I, QUALITY...
-
Business Analyst
7 months ago
Winnipeg, Canada Canada-West Assurance Full time**Job Summary**: Canada West Assurance (CWA), a division of Birchwood, is looking for a detail-oriented individual for the Business Analyst. CWA is a comprehensive provider of aftermarket insurance and protection programs for vehicles. Its vision is to be the recognized leader in the automotive Finance & Insurance industry. The Business Analyst will play a...
-
Junior Business Analyst
6 months ago
Winnipeg, Canada Canada-West Assurance Full time**Job Summary**: Canada West Assurance (CWA), a division of Birchwood, is looking for a detail-oriented individual for the Junior Business Analyst. CWA is a comprehensive provider of aftermarket insurance and protection programs for vehicles. Its vision is to be the recognized leader in the automotive Finance & Insurance industry. The Junior Business Analyst...
-
Quality Assurance Analyst
7 months ago
Winnipeg, Canada Togetherwork Full time**This is a temporary Union position potential duration 12 to 18 months.** **Job Summary**:The Quality Assurance Analyst is responsible for creating an end-to-end test plan, executing the plan, and managing all activities in the plan to ensure that all the objectives are met, and that the solution works as expected. Working hours are 9am CST - 5pm CST...
-
IT Quality Assurance Analyst
6 months ago
Winnipeg, Canada Cabela's Full time**Summary**: Reporting to the IT Ecommerce Manager, Technology, the Quality Assurance Analyst is responsible for developing and executing software test plans to identify software defects and their causes. They will be responsible for testing activities focused on product functionality, performance, reliability, stability, and compatibility of product lines....
-
Junior Quality Assurance Analyst
6 months ago
Winnipeg, Canada Niche Technology Inc. Full time**About Niche** Niche Technology designs, develops, supports, and implements an advanced police Records Management System (RMS). Our current offering, NicheRMS, covers the full breadth of police operations as standard, out-of-the-box functionality that is available now and in live production use. It is a single, integrated operational police information...
-
Quality Assurance Team Lead
6 months ago
Winnipeg, Canada AutoCanada Inc. Full time**Quality Assurance Team Lead** **Winnipeg Office** **Winnipeg, MB** Are you looking to drive your career forward? We are looking for a software quality assurance expert to build and lead a team of QA analysts and automation specialists focusing on regression and release testing. We want someone who is or wants to be a great leader, is highly organized,...
-
Investigator I
7 months ago
Winnipeg, Canada Canada Life Assurance Company Full timeInvestigator I **Description: - Permanent Full Time- We are looking for an**_ Investigator - Detection, Prevention & Integrity Services, Group Customer (DPIS)_** - The Investigator is a key member of the health and dental team that delivers robust and effective health and dental claims fraud prevention to Canada Life customers. The main function of the...
-
Support Analyst I
6 months ago
Winnipeg, Canada Clear Concepts Full timeWe're looking for a **Support Analyst** **I* in **Winnipeg* to join our team. Clear Concepts is an IT award-winning company based in Winnipeg. We have been in business for over 20 years, assessing, deploying, and maintaining technology for business and non-profit organizations in Healthcare, Education, Transportation, etc. not only in Winnipeg but...
-
Quality Assurance/training Manager
6 months ago
Winnipeg, Canada IntouchCX Full time**About IntouchCX** **About the Job** We are seeking a Quality Assurance / Training Manager to deliver extraordinary results for our clients. Working closely with multiple departments, this role is responsible for identifying areas of opportunity, developing solution plans, coaching team members and ensuring key metrics are achieved. We're looking for a...
-
Winnipeg, Canada Compunnel Inc. Full timeAbout the RoleWe are seeking a highly skilled Senior Quality Assurance Analyst to join our team at Compunnel Inc.
-
Senior Quality Assurance Analyst
1 week ago
Winnipeg, Manitoba, A3C, Manitoba, Canada Compunnel Inc. Full timeAttributesAttributes that are highly desirable in this Senior Quality Assurance Analyst role are as follows: • Bachelor’s degree in Computer Science, Information Technology, or a related field • Five years of experience in software testing • Extensive hands-on experience executing Test Scripts, and documenting outcomes • Experience documenting test...
-
Quality Assurance Inspector
3 months ago
Winnipeg, Canada Buhler Versatile Inc. Full time**Job Overview** **KEY RESPONSIBILITIES AND DUTIES**: - Conduct product inspections in welding shop and other departments for I-Beam fabrication line. - Perform NDT for welding parts, visual and measuring inspections and Prepare inspection reports - Investigate non-conformances and determine disposition of non-conforming/ defective parts or components;...
-
Winnipeg, Manitoba, Canada Red River Mutual Full timeAbout the RoleWe are seeking an experienced Business Analyst to join our team at Red River Mutual. As a key member of our Analysis functional group, you will work with various stakeholders to gather and document business requirements and contribute to the design and delivery of quality software solutions.ResponsibilitiesYour primary responsibilities will...
-
Senior Software Quality Assurance Specialist
3 weeks ago
Winnipeg, Canada PrecisionERP Incorporated Full timePrecisionERP/IT is recruiting for a Senior QA Analyst for an ONSITE contract for initial 6-9 months with our partnered client in Winnipeg, MB.SUMMARY: The Sr. QA Analyst is responsible for the QA activities on development and maintenance projects with our client. This includes the validation of front-end and back-end systems, understanding the business and...