Job Description

Location: Calgary, AlbertaType of Employment: Permanent - Full timeClosing Date: Friday, August 26, 2022 (Applications are accepted until 11:59 PM MST)About Us:
Northern RNA Inc. is a new Canadian CDMO specializing in the production of nucleic acid products that support life-enabling work. Our goal is to work alongside our customers to provide scalable manufacturing capacity and to help them accelerate innovation in bringing their products from benchtop to bedside or field.About Our Opportunity: Quality Assurance Associate will be an individual who is experienced in the field of Good Manufacturing Practices (GMP) manufacturing. This candidate will support NRNA's quality assurance team to and provide quality expertise.Primary Responsibilities:

• Work with teams to prepare, review, master documents, executed documents, and summary reports as applicable (i.e., Batch records, specifications, qualification/validation protocols, etc.)
• Prepare, review, deviations, CAPA, Change Controls, SOPs, etc. as applicable
• Support cross functional teams when issues arise. On-call support may be required.
• Conduct quality line clearance sign offs
• Perform material release
• CoA review and approval
• Liaise with all departments to ensure products are released on time
• Work with team to maintain GMP in everyday practice
• Review and approve supplier qualification
• Support and participate with internal/external audits
• Coordinate activities to support with establishing cleanroom facility
• Work with the cross functional teams for validation activities associated with new equipment, processes, or system upgrades.
• Maintain flow of documentation in electronic QMS
• Assist end-users of electronic QMS by proving training on use of quality systems and procedures

• Issue documents and logbooks as required
• Provide quality oversight for activities such as design of systems and equipment to ensure that they comply with applicable regulations & International Standards.

• May perform other related duties as assigned.

Education, Work Experience, Knowledge, and Skills: Formal Education:

• Minimum Bachelor's degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.)

Work Experience:

• More than 4 years of experience in GMP production within the pharmaceutical, biotechnology, medical technologies, biologics, or similar industries.
• Experience working for a Contract Manufacturing Organization (CMO), a third-party testing facility, or a biotechnology company performing similar activities.

Knowledge and Skills:

• Strong English written and oral communication.
• Advanced understanding of quality management systems
• Strong knowledge and experience in GMP requirements.
• Sound knowledge of applicable regulatory frameworks
• Independent, detail-oriented, self-starter with excellent analytical skills, high level of critical thinking, and the ability to multitask and succeed in a team environment.
• Excellent time management
• Experience establishing customer-facing organizations and service models.

Working conditions:

• Physical environment: Majority of time spent in a comfortable position with frequent opportunity to move about at will.
• Physical effort: May have to lift/move materials during release, move documents
• Sensory Attention: Work activities involve need to concentrate on a variety of sensory inputs specifically visual attention for long durations, requiring close attention several times daily.
• Mental Pressures: High - Must have strong attention to details, be able to make decision with information present. Be able to approve documents and risk assess as required

What we offer?
We offer a highly competitive salary and company-paid benefits. Additionally, there are excellent opportunities for learning and growth while working alongside our teams of experts who are bright, collegial, and highly motivated and who are on the cusp of the mRNA vaccine science and technology era.Benefits:
Northern RNA Inc. offers its employees a wide range of benefits such as Health, Dental, Basic Life Insurance, General Illness (Long Term Disability), Vacation, Performance Bonus, on-site parking and Accidental Death and Dismemberment.Additional Information:

• Northern RNA Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Northern RNA Inc. will consider requests for Reasonable Accommodations.
• Northern RNA Inc. requires all employees to wear a face covering (mask) in indoor public premises.
• Location for this position is in Calgary, Alberta. Candidates must be located within commuting distance or be willing to relocate to this area. Canadian citizens and those legally entitled to work in Canada are encouraged to apply. We are currently unable to sponsor.

Northern RNA Inc. is committed to a diverse and inclusive workplace. Northern RNA Inc. is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, gender, gender identity, gender expression, sexual orientation, age, marital or veteran status, pregnancy or disability or other legally protected status. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.Offer of employment is conditional upon the completion of all applicable background checks and confirmation of credentials, the results of which must be satisfactory to the employer. We thank all applicants for the interest, however, only those selected for an interview will be contacted.Job Types: Full-time, PermanentFlexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Calgary, AB T2A 7H8: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's Degree (preferred)

Application deadline: 2022-08-26