Senior Quality Associate/ Associé principal (e), Assurance qualité

EyeBio; Charlottetown; On-site; CAD 61,000 - 106,000; Full time

Job summary

A healthcare company in Charlottetown is seeking a Quality Assurance Manager to oversee compliance and quality metrics. This role requires a Bachelor’s degree and at least 5 years of experience in Quality Assurance or Good Manufacturing Practices. Candidates should be critical thinkers with excellent communication skills. The expected salary ranges from CAD 61,900 to CAD 105,300, and applicants must have legal work authorization in Canada.

Qualifications

• Minimum of 5 years in Quality Assurance or Good Manufacturing Practices
• Experience in cross-functional collaboration
• Prior experience in root cause analysis

Responsibilities

• Manage Quality Assurance projects for compliance and productivity.
• Prepare risk assessments and Standard Operating Procedures.
• Conduct inspections and prepare for regulatory assessments.

Skills

Independent work capability

Critical thinking

Communication skills

Education

Bachelor of Science degree or equivalent

Tools

MS Office

Adobe

Job description

Main Responsibilities & Duties

• Management of Quality Assurance projects with a focus on compliance, productivity, and improvement of quality metrics. Leads these teams through project planning, organization and tracking of project deliverables.
• Preparation of risk assessments, protocols, Standard Operating Procedure(s), training materials and gap assessments.
• Work closely with Quality Assurance stakeholders on multidisciplinary projects that require quality consultation; this may include management of multi-stakeholder projects that directly influence compliance and manufacturing outcomes.
• Complete Technical and Quality Agreements.
• Work closely with Quality Assurance stakeholders to provide input into protocol development and to ensure protocols are compliant with our company's and GMP standards.
• Review and approval of executed validation / qualification protocols and reports.
• Manage Quality Assurance regulatory and internal inspection preparation. Participates in a lead support role during inspections.
• Conduct site self-inspections and Quality Assurance walkthroughs.
• Release of equipment and facilities.
• Supporting the implementation of our company's Animal Health Quality Manual as required.
• Shared responsibility for the following quality systems: change controls, quality events and investigations, Corrective and Preventive Actions, and out of specification.
• Provides initial assessment of quality events, investigations, Corrective and Preventive Actions, and OOS for completeness and compliance.
• Leads cross functional teams (when required) in investigations and analysis to determine root cause and aids in the resolution of issues.
• Approves deviations.
• Preparation and approval of change controls and impact assessments.
• Tracking and trending of all systems to ensure timely closure and follow up where required.
• Other duties as required.

Qualifications and Experience

• Minimum of a Bachelor of Science degree or equivalent.
• At least 5 years in Quality Assurance and/or current Good Manufacturing Practices facility operation experience.
• Crossfunctional collaboration experience with multiple teams (indirect or direct leadership experience is an asset).
• Proven ability to work independently due to the highly independent nature of this role.
• Focused on achieving goals and persistent when faced with obstacles.
• Adaptable to quick changes in required activities or duties.
• Thinks critically to support the needs of Quality Assurance but also considers business impact.
• Excellent communication skills, in both verbal and written form.
• Language requirement: English.

Additional Preferences

• Proficiency with business applications such as Adobe, MS Office, Word, Excel, Access, Project, Visio, and PowerPoint.
• General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
• Good problem-solving skills.
• Experience in root cause analysis.
• Work effectively in cross-functional teams.

Health and Safety

• Display Screen Equipment 2/3 time.
• Sittnig 2/3 time.
• Lift <5Kg <1/3 time.
• Vision close, distant and color yes.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

All candidates are required to have adequate and legal work authorization to work in Canada before applying for posted positions. Only candidates with valid work authorization, not requiring company sponsorship in the course of their employment with our company will be considered in the recruitment process.

Expected CAD salary range: $61,900- $105,300.