Eurofins is hiring a Data Reviewer / Technical Writer to join our team. In this role, you will ensure compliance with regulations like Cosmetics Regulations, the Food and Drugs Act, and FDA/EMA standards for our quality assurance clients. You will be a key player in maintaining the integrity and accuracy of our critical quality documentation.
What You'll Do
- Review and determine the status of quality documents, including raw laboratory data, validation studies, and calibration reports.
- Review and release laboratory results, investigating out-of-specification and out-of-trend findings.
- Perform technical writing for documents such as Method Validation Protocols.
- Provide support for maintaining the Quality System, including drafting and updating quality procedures.
- Assist with internal and external audits, and manage the internal auditing program as required.
- Ensure all reports and raw data comply with GMP standards, study protocols, and SOPs.
- Interact with department staff to gather information for reports and present findings on deficiencies.
- Log and review complaints, compiling required GMP documentation for their evaluation.
- Manage the ongoing tracking and maintenance of GMP documents and archives.
- Develop, review, and revise training materials and assist in training new staff.
- Initiate and investigate deviations, perform risk assessments, and manage CAPA plans.
- Assist in Change Control procedures, trending analysis, and report preparation.
- Adhere to, circulate, and ensure staff follow Standard Operating Procedures.
- Assist with maintaining Health Canada and FDA accreditation.
- Summarize information and prepare reports for Management Review.
What We're Looking For
- A degree in a science-related discipline.
- 2-5 years of QA experience in a GMP or ISO testing/production facility.
- Knowledge of GMP requirements.
- Must speak and write English fluently with excellent, articulate communication skills.
- Excellent organizational skills with a high level of accuracy and strong attention to detail.
- Ability to work independently and collaboratively, multitask, and remain calm under pressure.
- A high level of professionalism, maturity, and discretion when dealing with confidential matters.
- Exceptional computer skills with high proficiency in Microsoft Office (Outlook, Word, Excel).
- Must be proactive, self-disciplined, and demonstrate a high level of productivity.
- A satisfactory work performance and attendance record.
- Willingness to learn, retain information quickly, and apply knowledge to various scenarios.
Technical Stack
- Microsoft Office Suite: Outlook, Word, Excel
Team & Environment
You will report directly to the Quality Assurance Manager or their designate, working within a collaborative, team-based department.
Benefits & Compensation
- Health & dental coverage
- Life and disability insurance
- RRSP with a 3% company match
- Paid holidays
- Paid time off
Work Mode
This is an onsite position located in the GTA, Ontario.
Eurofins is an equal opportunity employer. Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.
