Quality Regulatory Affairs of Medical Devices jobs

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

Administrator, Quality Assurance will support the QA Activities such as Document Record Management, Training activities, and other quality systems activities for QA. Personnel will be round of in supporting Quality System Management activities, such as change in change control, risk assessment, operational and administrational work

** Please note this position requires full-time on-site presence.

Key Responsibilities, include but are not limited to:

QA Oversight

• Perform, assess, review and approves deviation investigation and CAPA implementations
• Able to handle and lead root cause analysis and uses appropriate tools for determining the most probable root cause(s).
• Able to perform and implement a CAPA determined through the investigation results.
• Quality oversight in Quality Systems pertaining to Incident (Deviation), Investigation, CAPA and Nova- RM, and FP applications.
• Maintain QA compliance with company and regulatory standards.
• Support Document Record Management and change controls processes/ activities

Document & Records Support

• Process and routing of controlled quality documents (SOPs, Batch Records, Specifications, protocols) for distribution, review and approval as directed.
• Execute day-to-day tasks within the electronic Quality Management System (eQMS), including document formatting, uploading, and archiving.
• Assist in organizing physical and electronic archives to ensure files are accurately indexed, secure, and retrievable.

Training Program Support

• Perform Administrator duties in the Learning Management System (LMS) in support of QA DRM and Training, including activities such as maintaining and updating training items and users in coordination with department managers and QMS requirements.
• Prepare training materials and aid others in creation of training material in the Learning Management System (LMS).

Risk Analysis and QA Systems

• Have a broad understanding in risk analysis and mitigation – FMEA, HAZOP etc.
• Detail oriented- in performing the impact assessment, change control, investigation details, determination of CAPA and ensure final report compliance.
• Participate in the development and establishment of Quality Management Systems.

Data Review and Approval

• Review and approve analytical data for Raw Materials and Products– chemistry or microbiological testing for accuracy and completeness in the electronic systems.
• Support the deviation investigation related to Quality Control and Microbiology. (OOS, OOT, etc.)
• Support equipment calibration/ maintenance investigations as required.
• Responsible for review of GMP documentation – Master batch records, specifications, test methods, and sampling / labelling.
• Review and approve batch related documentation for raw materials, intermediates and finished products.
• Support assignment of lot disposition ensuring all testing requirements and manufacturing records are reviewed in compliance to GMP standards.

Collaboration and Support

• Provide guidance and training to QA Associates and other Departments
• Write and review and approve SOP’s/ WI’s if required.
• Help maintain archive documentation and retrieval.
• Provide QA operational support in different QA initiatives.
• Participate and contribute to audit inspections (Internal and External) in terms of QA documentation as necessary.
• Collaborate with Operational teams, Clients, stakeholders for any projects or requirements

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Minimum of bachelor’s degree in engineering and/or information technology, life sciences, or a related field

Experience:

• 3+ years of QA experience in the pharmaceutical or medical device industry
• At least 3 years of experience required in handling deviation investigations, change control and CAPA.
• Expertise in the application of Health Canada and FDA cGMP requirements including 21 CFR Part 11, 21 CFR Part 210 & 211, EU Annex 11, ICH Q7 and internal API procedural requirements is required.
• Expertise in electronic quality management systems (QMS) and QMS product management is required.
• Able to drive requirements to closure and work with Quality to develop guidelines and procedures to formalize and educate colleagues on needs and expectations of data integrity, ALCOA+.
• Demonstrated analytical and conceptual problem-solving skills and the ability to synthesize and clearly communicate complex findings to various stakeholders is an asset

Personal Competencies

• Strong customer focus with a demonstrated ability to work seamlessly with business sponsors and technologists.
• Exhibits curiosity, a commitment to learning, and exploring new technology.
• Results-oriented and process-driven, with high expectations of self and the team.
• Excellent communication skills with demonstrated experience in making articulate and effective oral presentations to different audiences.
• Must be self-confident, outgoing, and able to communicate effectively upward and downward the management chain.

Working Conditions:

· Required travel between Edmonton API sites.

· This position requires you to be on site.

Additional Required Documents to Support Application

· Applications submitted without a resume AND cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1–3% of base salary, in accordance with program terms.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process, please contact careers@appliedpharma.ca.

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.

Before employment, successful candidates will be required to meet the requirements of a pre-employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

Applicants with education credentials earned outside of Canada should have their credentials evaluated by World Education Services or the International Qualifications Assessment Service (IQAS).

This position will remain open until filled.

Work Location: In person