Associate Quality Assurance Jobs

General management and administrative skills.

Ensures that process and product specifications and requirements, established by CBS, regulators and customers, meet or exceed their expectations.

Directs the execution of Quality Assurance activities at all CBS sites, communicates process quality requirements while promoting and responding to feedback.

Requirement to be on call for approximately one week once a quarter, 24/7 to support the national team.

Post-secondary level education in sciences from a recognized academic institution, preferably a bachelor’s degree in Pharmacy or Biological Sciences.

A minimum of seven years of experience in an established drug-manufacturing environment.

Understanding of ISO 13485 requirements by certification.

Strong understanding of business practices with fundamental understanding of project management methodology and administrative functions.

Support regulatory compliance/agency audit and audit related research, documentation and preparation, in accordance with business goals, regulatory compliance, and legal requirements.

Manage training profiles and training matrix for all departments.

Work with all departments to obtain an in-depth understanding of the documentation requirements.

Work in accordance with Diva International Inc.’s Quality Policy and B-Corp set of standards, ISO, GMP and FDA requirements as applicable.

Maintains QA documents in Astellas Document Management System (ADMS).

If your skills and experience match our needs, please email your resume to: [email protected].

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.

Assists the QA Manager with auditing of manufacturing locations if required.

Be part of the foundation of a new, growing industry and make your mark

Autonomy and key decision-making opportunities

Work in a fast-paced, collaborative environment with opportunity for growth both personally and professionally

Collaborate with Higher Education Product Managers and Developers on design and testing results.

Act as customer advocate in understanding requirements, while guiding on principles in the development and quality release of Higher Education functionality.

2+ years’ experience working in Higher Education systems.

Lead testing Workday Higher Education functionality.

2+ year experience in functional end-to-end workflow testing, including test planning and execution.

A Higher Education professional, implementer or business analyst looking to transition into testing the design and configuration of enterprise applications.

Comprehensive benefits and an RRSP program where we match up to 5% of your earnings

Minimum 2 years in a manufacturing environment, with experience in Quality Control preferred.

A general knowledge of inspection procedures.

Demonstrated experience with MS Word, Excel, and PowerPoint.

Good record keeping and organizational skills.

Strong employee relations, interpersonal and verbal/written communication skills.

Experience in vendor qualification and audit.

B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred.

2-5 years of experience in a GMP or equivalent regulated environment

Training and experience in documentation control, change control, CAPAs and review of quality records.

Ability to work independently and possess excellent organizational skills.

Excellent oral and written communication skills

Experience working in a manufacturing, pharmaceutical and/or GMP facility is an asset

Advanced computer skills in Microsoft Office Suite (Outlook, Excel, Access, Word)

Excellent communication skills — verbal and written

Vision abilities required by this job include close vision.

Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance);

Catalent offers rewarding opportunities to further your career!

Review reports for compliance with protocols, quality system and regulatory requirements.

A B.Sc or M.Sc in the life sciences with 1-5 years of experience in a GMP or equivalent regulated environment

Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records

Proficiency in the English language both written and oral and excellent communication skills; detail-oriented

Group Health & Dental Benefits

Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Close-out.

Working knowledge of quality management systems and 1-2 years of experience preferred.

Coordinate with warehouse management to ensure compliance with all GMP protocols, and warehouse efficiency and to make improvements wherever possible.

Strong knowledge of all products and their handling and storage requirements

Ensure all regulatory requirements such as proper handling/shipping and storage conditions are met.

Implement and manage CAPA, Non-conformance, product complaints and other quality issues.

Educate and manage all warehouses on any tasks in the GMP area which may affect product quality.

·Monitoring and verification activities as part of the Quality Management System.

·Support with deviation management, corrective action plans and risk assessments.

· Support the QAP with communication, education, and on-going training

·Record verification, collection, organization, and data entry of data/information.

·Assist the QAP in ensuring GMP and GPP compliance throughout the facility.

·Assist all functional departments in establishing systems to eliminate GPP gaps.

General management and administrative skills.

Ensures that process and product specifications and requirements, established by CBS, regulators and customers, meet or exceed their expectations. 

Directs the execution of Quality Assurance activities at all CBS sites, communicates process quality requirements while promoting and responding to feedback.

Requirement to be on call for one week once a quarter, 24/7 to support the national team.

Post-secondary level education in sciences from a recognized academic institution, preferably a bachelor’s degree in Pharmacy or Biological Sciences.

A minimum of seven years of experience in an established drug-manufacturing environment.

Maintaining working knowledge of regulatory requirements, ICH GCP principles, and clinical trial processes

Assisting in the creation, review, revision, and management of procedural documents

Possess a working knowledge of and experience with GCP

Prior QA experience supporting professional services within CRO

Must possess strong Excel, Word, and PowerPoint skills

Ability to demonstrate strong verbal and written communication skills as well as the ability to understand and coordinate multiple projects

Possess strong file management skills and organization, able to manage multiple engagements simultaneously

Plan, organize and control multiple responsibilities and resources to achieve Audit, Review and Notice to Reader engagement objectives.

Share and transfer knowledge within the team.

3+ years of experience in a Canadian public accounting environment

Thorough understanding and experience working with International Financial Reporting Standards (IFRS) and the Accounting Standards for Private Enterprises (ASPE)

Experience with Canadian corporate taxes

Maintaining working knowledge of regulatory requirements, ICH GCP principles, and clinical trial processes

Assisting in the creation, review, revision, and management of procedural documents

Possess a working knowledge of and experience with GCP

Prior QA experience supporting professional services within CRO

Must possess strong Excel, Word, and PowerPoint skills

Ability to demonstrate strong verbal and written communication skills as well as the ability to understand and coordinate multiple projects