QA Specialist II

Description:
The position of Quality Assurance Specialist II is within our Infectious Disease Business Unit located at Scarborough this role you will under minimal direction perform a wide variety of activities to support the Quality Management System. This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:
The following activities may be assigned as applicable:

Quality System Management

• Review production batch records (DHRs) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records.
• Report deviations in these records and assure they have been addressed and resolved prior to issuing approval.
• Conduct spot-check inspections/audits of production operations
• Participate in the internal audit program
• Write review and approve Standard Operating Procedures (SOPs) as necessary
• Assist with and may write validations/test protocols as necessary
• Assist in testing of complaint samples and stability samples and report results out of acceptance limits
• Provide backup to other Quality Specialists
• Initiate and author Deviations and Quality Incidents (QI)
• May administer the calibration program
• May administer the document control system
• May administer the Deviation Quality Incident and CAPA programs
• May organize the long-term stability program and be responsible for administering the sample retention program
• May administer the Quality Records program and assist and act as backup to the Document Control Specialist II
• Train new and current Quality Assurance Technicians and Specialists as needed
• Other duties may be assigned.

Change Control Management

• Change Management Documentation
• Assignment of Design History File numbers
• Compile and maintain quality system records associated with design change projects including project definitions first-lot-to-stock product qualification records etc.
• Ensure records for design change projects are complete and align with SOPs
• Manage organization storage and archival of documentation and records associated with design changes and labeling

Labeling Process Administration:

• Provide proofreading of product labeling prior to team review and approval
• Initiate execute and implement label changes in coordination with interdepartmental and external stakeholders

Change Control Execution:

• Assist with implementation of product changes in conjunction with project leads
• Manage assigned Design Change projects (typically associated with product labeling)
• Other duties may be assigned.

BASIC QUALIFICATIONS EDUCATION:

• Bachelors Degree in Chemistry Biology Life Science or other related technical field in a scientific or technical area or the equivalent combination of education and experience
• Minimum three years in a Quality Assurance role for manufacturing.

PREFERRED QUALIFICATIONS: 3 years prior experience in a Quality Assurance role or similar support role in the medical device industry

COMPETENCIES:

• Ability to follow procedures and accurately document results
• Knowledge of site software for inventory management document control and quality incident tracking
• Good working knowledge of Excel and Microsoft Word software
• Ability to understand manufacturing processes of Company products and ability to recognize deviations from approved documented procedures
• Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals
• Ability to write routine reports and correspondence
• Ability to speak effectively before groups of customers or employees of organization
• Ability to interpret a variety of instructions furnished in written oral diagram or schedule form
• Ability to apply mathematical concepts such as fractions percentages ratios and proportions to practical situations
• Attention to detail