Document & Data Reviewer - Eurofins Cosmetics & Personal Care, Inc
Eurofins View all jobs
- Toronto, ON
- Permanent
- Full-time
- Review and determine the status of the quality documents (including, but not limited to, raw laboratory data, validation studies, logbooks, qualification and calibration reports).
- Review and release of laboratory results.
- Review out-of-specification, out-of-trend and other investigations
- Providing support with maintaining Quality System, including drafting and updating quality procedures.
- Perform technical writing tasks such as Method Validation Protocols
- Assisting with internal and external audits.
- Ensuring that all reports and accompanying raw data are according to GMP, accurate, correct, and acceptable according to the study protocol, methods, and relevant SOPs.
- Interacting with department staff to acquire information for report writing and auditing purposes and present information to staff regarding deficiencies and areas of improvement.
- Log and review complaints; compile required GMP documents for the evaluation of complaints.
- Perform and manage the internal auditing program if required.
- Manage the ongoing tracking and maintenance of GMP documents
- Develop, review and revise training materials. Assist in training of new staff.
- Evaluate and summarize instrumentation data in final reports.
- General record-keeping practices according to local and global SOPs including maintenance of on- and off-site archive.
- Assist in issuing logbooks and forms when needed.
- Review training records and generate associated reports if required.
- Initiate and investigate deviations if required.
- Perform risk assessment pertaining to discovered deviations.
- Initiate and conduct Corrective Action and Preventative Action (CAPA) plans.
- Initiate and assist in Change Control procedures.
- Assist in and perform trending and prepare reports as per relevant procedures.
- Adhere to the Standard Operating Procedures.
- Circulate Standard Operating Procedures and follow up on training requirements.
- Ensure that all staff members are always following the Standard Operating Procedures.
- Assist with the maintenance of Health Canada and FDA accreditation.
- Assist in summarizing information and report preparation for Management Review.
- Attend staff meetings.
- Any other duties as delegated by the Quality Assurance Manager or designate.
- Knowledge of GMP requirements;
- 2-5 years QA experience in a GMP or ISO testing or production facility;
- Must speak and write English fluently;
- Must possess excellent communication skills, both written and verbal;
- Must be articulate;
- 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;
- Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel);
- 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.
- Degree in a science-related discipline;
- Computer proficiency - Microsoft Office, especially Excel.