QA Compliance Specialist
2 weeks ago
**Location**:
***
- Mississauga, ON**Date Posted**:
***
- 5/8/2023**Job Number**:
***
- JO-2305-1605**TITLE**: QA Compliance Specialist (Internal Audit Focus)
- **DEPARTMENT**: Quality Assurance
- **CURRENT GRADE**: 8
- **POSITION REPORTING TO**: QA Compliance Manager or Supervisor**General Description**
QA Compliance Specialists ensure Bora’s products and processes meet established quality standards. They provide quality support for a myriad of areas including GMP compliance requirements to always ensure inspection readiness of the site. Their key responsibilities are listed but not limited to the following.**Key Responsibilities**
- Provide GMP compliance support for various projects and initiatives including product transfers.
- May be required to manage the internal audit program, including but not limited to planning, executing, and reporting internal audits, endorsing, and monitoring CAPAs and maintaining program KPIs. Required to participate in regulatory and customer inspections in various roles as required.
- May be required to issue or approve Master Data, Standard Operating procedures, Master forms, Technical Reports, Risk Assessments, Raw Material and Product Specifications, Analytical Test Methods, Supplier or Customer Quality Agreements and other Quality related documents.
- May be required to manage various aspects of the supplier management program including the assessment of supplier compliance documentation to ensure regulatory compliance, supplier change and non-conformance notifications and regulatory quality alerts to ensure on-going site compliance.
- Review site master data and other internal information to ensure on-going compliance through the interpretation of customer/supplier requirements, regulations, and data.
- Analyze processes and systems, identify vulnerabilities/gaps, establish remediation plan and lead implementation activities.
- Lead or support investigations using root cause analysis tools with multi-functional groups and develop CAPA plans or confirm effectiveness of CAPA plans when assigned.
- Support other team activities including but not limited to entering data in various electronic systems, generating monthly quality metrics, drafting declaration statements etc.
- Lead or support cGMP training of staff.
**Qualifications**
**Experience and Skills**
- Minimum 5 years’ experience in a similar role in the pharmaceutical or related industry
**Education**
Required:
- Bachelor’s Degree or College Diploma in Science, Engineering, or a related field or equivalent on the job experience through years of service in the Pharma or related industry
Preferred:
- Strong knowledge of regulatory framework and demonstrated ability to interpret regulations and make informed decisions.
- Support projects or change initiatives and provide advice on compliance requirements.
- Ability to effectively communicate cGMP requirements to individuals.
- Excellent interpersonal and communication skills.
- Good technical writing skills. Thorough attention to detail is key for this role.
- Good computer skills and data management skills
-
Quality & Compliance Specialist
1 day ago
Mississauga, Canada Juno Pharmaceuticals Full timeThe Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...
-
Quality & Compliance Specialist
4 weeks ago
Mississauga, Canada Juno Pharmaceuticals Full timeThe Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...
-
Quality & Compliance Specialist
3 weeks ago
Mississauga, Canada Juno Pharmaceuticals Full timeThe Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...
-
Quality & Compliance Specialist
3 weeks ago
Mississauga, Canada Juno Pharmaceuticals Full timeThe Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...
-
Hipaa Compliance Specialist
4 weeks ago
Mississauga, Canada BoomerangFX Full time**Position Title**: HIPAA Compliance Specialist **Term**: Contract (30 days) **Area of focus**: HIPAA Compliance, Compliance Software (Vanta or Darta), Policy Implementation **Work Location**: position is 100% on-site in Mississauga (Financial Dr.) **Why BoomerangFX?** BoomerangFX is more than just a SaaS tech company - we are one of North America’s...
-
Project QA Specialist
4 days ago
Mississauga, Canada SNC-Lavalin Full time**Why join us?** SNC-Lavalin provides cutting-edge engineering, procurement, construction and financing solutions to projects in more than 100 countries around the world. From the Canadian Arctic to the Southern African region and Australasia, our multicultural workforce is driven by a fierce pride in their work and a pioneering vision. SNC-Lavalin is...
-
Trade Compliance Specialist
12 hours ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
3 weeks ago
Mississauga, Canada IKO Full timeDescription The Trade Compliance Specialist is responsible for ensuring we maintain compliance with all cross-border shipments and current on all reporting requirements. This is a permanent full-time opportunity based in our Mississauga office. WHAT’S IN IT FOR YOU? Competitive compensation/pay package Dental/Vision/Medical benefits Life...
-
Trade Compliance Specialist
4 weeks ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES: Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure the smooth movement of...
-
Trade Compliance Specialist
5 days ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
4 weeks ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES: Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure the smooth movement of...
-
Trade Compliance Specialist
4 weeks ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES: Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure the smooth movement of...
-
Trade Compliance Specialist
4 weeks ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES: Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure the smooth movement of...
-
Quality & Compliance Specialist
4 weeks ago
Mississauga, ON, Canada Juno Pharmaceuticals Full timeThe Quality & Compliance Specialist jointly with the Manager, Quality is responsible for the quality assurance, quality control and quality compliance activities in support of the importation and distribution of JPC’s drug products. The candidate will support the Manager, Quality in leading the operational oversight, decision making and performance of...
-
Trade Compliance Specialist
1 day ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES: Maintain master list of tariff classifications including supporting documentation for documentation for classification. Contact secondary suppliers to determine the trade status of purchased products. Supply required paperwork to end-user customers when required. Liaise with Brokers and Supply Chain to ensure...
-
Trade Compliance Specialist
1 day ago
Mississauga, Canada Gateway Recruiting, Inc Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
10 hours ago
Mississauga, Canada Gateway Recruiting - Gateway To Global Careers - Contingent Retained Contract Recruiting Services Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
4 weeks ago
Mississauga, Canada Gateway Recruiting Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
2 days ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
-
Trade Compliance Specialist
2 days ago
Mississauga, Canada Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services Full timeJOB RESPONSIBILITIES:Maintain master list of tariff classifications including supporting documentation for documentation for classification.Contact secondary suppliers to determine the trade status of purchased products.Supply required paperwork to end-user customers when required.Liaise with Brokers and Supply Chain to ensure the smooth movement of goods...
