We are looking to fill a full time 12 month contract position (possibility of full time) in the Quality Assurance department.
Work location/office is in Ottawa, Ontario with possibility of working remotely.
The QA Specialist position is responsible for providing professional support to the staff of the Quality Assurance Department.
This position is reports directly to the Sr. QA Manager and/or designate.
The ideal candidate in the QA Specialist position will be able to work independently with minimal supervision. The incumbent must be energetic, exceedingly well-organized, flexible, and enjoy the challenges of supporting a team. The incumbent must have the ability to interact with staff in a fast-paced environment, consistently under pressure, while remaining proactive, resourceful, and efficient. A high level of professionalism and confidentiality is crucial to this role.
Key Accountabilities for this Role:
- Review and assessment of technical documentation and timely review of product for quality release.
- Preparing, maintaining, managing and tracking change controls
- Maintain of current Good Manufacturing Practices relating to supply management, distribution, investigations, change controls, deviations, CAPAs etc.
- Support all GMP compliance related as per the Health Canada requirements
- Interact with regulatory and other staff to identify trends in non-conformance issues, customer complaints and deviations
- Preparation of SOPs and/or SOPs revisions as per the business needs and training respective staff including periodic GMP trainings as required.
- Preparation of Annual Product Quality Reviews(APQRs)
- Conduct independent investigation and resolve complex quality issues
- Support customers with all technical and compliance requirements
- Interact with suppliers to obtain necessary documents, stability updates etc. to maintain and support customers
- Audit 3rd party laboratories and warehouses for GMP compliance as per Health Canada requirements.
- Review and assessment of technical documentation.
Bachelor of Science in Chemistry, Microbiology, or Life Science;
At least 3 years of previous Quality Assurance experience (Regulatory experience is an asset), however candidates must have an educational background in Quality/Regulatory Affairs.
Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel); Previous experience in RA/QA is considered a strong asset.
- Must speak and write English fluently, excellent communication skills, both written and verbal
- Must be articulate and excellent organizational skills
- High level of accuracy and strong attention to detail;
- Ability to work independently, while supporting a collaborative, team-based department
- Ability to multitask and remain calm under pressure;
- High level of professionalism, maturity, good judgment, and discretion when dealing in confidential matters
- Must be proactive, self-disciplined, and able to demonstrate a high level of productivity
- Demonstrate satisfactory work performance and attendance record
- Willingness to learn with the ability to retain information quickly and apply knowledge to various scenarios.
Reference ID: QA SpecialistApply Now
Contract length: 12 months
Expected start date: 2022-01-17
Job Types: Full-time, Temporary
We are respecting all Covid-19 recommendations made by the Government of Ontario as well as daily disinfection of the office. Masks are mandatory.
We are an equal opportunity employer and welcome applications from all interested parties. We thank you for your interest, however, only those candidates selected for an interview will be contacted.
Potential Candidates can email firstname.lastname@example.org stating a specific interest area such as :
- Customer facing functions (Sales and Operations)
- Support functions (Administration, Compliance, and Finance)
- Quality Assurance Specialist (QA department)
Your details will stay on the database till a position arises and your profile fits the position. Accommodation is available upon request for applicant and employees with disabilities.
At Marcan, we value inclusion and team work.