Life Science Quality Assurance Specialist III Job Mississauga area,Ontario Canada,Quality Assurance

Job Summary

The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. In this role the candidate will mentor and train new personnel on the Quality System(s). The Quality Specialist III will partner with stakeholders to improve the quality program and quality culture within the organization.

The candidate should have strong written and verbal communication skills to foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Maintains a culture of quality awareness, teamwork, and cooperation with Quality customers.

Provide Quality oversight, support and engagement as needed by Operations.

Owner of Quality Management System Processes such as:

Document Control Program: review, approval, and maintenance of company Standard Operating Procedure via electronic Document Quality Management System. Ensuring stakeholders are adhering to company policies and templates.

Change Management Program:
Review, approve and track changes to approved procedures, validated software and processes, qualified equipment. Review the change task completion. Track and facilitate investigation in cross functional impacted teal to support closure of Change Control.

Deviations and Nonconformances:
Review, approve and monitor the events and deviations. Complaint handling and investigations Track and facilitate investigation in cross functional team discussions in support of closing Quality Events

Supply/ Vendor Management:
Supplier qualification, reassessment activities, quality agreements, quality score cards. Oversee the process is maintained and approved according to processes.

Validations:
Review and approval of equipment, systems validation/ qualification, and any design transfer to operations

Quality Metrics:
Perform trending analysis and reporting of quality indicators. Identification or risk and process improvements into operations.

Reviews chart and records for completeness of all required testing, specifications and documents for various processes.

Compliance:
Audit plan and reporting to applicable standards. Review and approval of corrective action and supporting evidence. Aid in audit hosting and preparation. Aid in tracking and trending of internal and external findings, investigation and implementation of corrective/ preventive measures.

Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.

Gather performance metrics and coordinate Management review inputs from various contributing departments.

Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.

Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.

Create and implement a training program for the QMS processes to educate Quality Assurance customers.

Perform other Quality Assurance Duties as required.

Travel: Less than 5%

Knowledge, Skills and Abilities:

Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations.

Familiarity or experience with the following is strongly preferred:
Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.

Computer

Skills:

Knowledge of Master Control, or similar eQMS a plus

Demonstrated experience and proficiency in Microsoft Office applications, Word, Excel and PowerPoint.

Adaptability

Responds effectively to changing constraints.

Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.

Understands the drivers of change and anticipates the implications of changing political and practical circumstances

Applies a preventative instead of corrective approach Attention to Detail

Checks information, picks up inconsistencies and mistakes and can make detailed comparisons between similar sources

Positive work attitude that supports teamwork and continuous improvement.

Decision Making

Makes pragmatic decisions based on range of factors

Able to make decisions quickly where necessary, based on incomplete information

Demonstrates logic to back up decisions

Excellent critical analytical skills – ability to find root cause of why and issue occurred.

Initiative

Identifies ways to improve processes/situations

Takes responsibility for improvements or solving problems.

Must display eagerness to learn and continuously improve.

Sets own standards above prevailing standards, shows dissatisfaction with substandard or inefficient activities Interpersonal…