Eurofins NSC Canada Inc
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics,
discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
Basic Function: The Quality Assurance Manager position is a supervisory position reporting directly to the President. The Quality Assurance Manager is responsible for monitoring and maintaining all laboratory Quality Systems in compliance with cGMP and ISO 17025:2017 requirements.
- Maintain methods, SOPs, training, analyst books, audit reports, CAPAs;
- Maintain storage of master documents, retrieval, security, authorization and distribution of working copies;
- Maintain completed management reports.
- Maintain the Quality management System to ensure quality compliance in regards to Health Canada and the FDA requirements
- Ensure compliance to the regulatory and the company’s data integrity requirements.
Document Change Control / EtQ Document Management software
- Revise SOPs; prepare and approve change control procedures;
- Approve all SOP revisions;
- Verify implementation of changes.
Training / EtQ Training Module
- Conduct GMP/ISO training;
- Conduct new employee training and verify satisfactory completion of training.
- Handle all personnel administration and management;
- Enable and encourage a motivated and responsive QA team which is able to adapt to business needs
- If discipline is required, to be handled immediately with HR involvement.
- Handle internal and external audits, including regulatory;
- Perform internal audits on a regular basis;
- Prepare response to auditor’s reports.
- Evaluate investigation reports;
- Approve and verify conformance and corrective action;
- Issue CAPAs.
- Supervise activity of all data reviewers;
- Review and approve all documentation generated in the laboratory, including calibration and external contractors.
- Supervise activities of calibration department;
- Oversee scheduling of equipment, tools, and instruments.
- Maximize and leverage relationships to increase customer base and retention by upselling services and providing support.
Monthly management meetings
- Provide status update on department;
- Maintain minutes of meeting;
- Provide outline of deviations, corrective, and preventative actions.
- Any other duties as requested by President
- 5-10 years in a Quality role, preferably in a contract testing laboratory
- Hands-on lab experience REQUIRED, ideally in pharma
- BSc or MSc in Chemistry or related discipline; additional certificate or diploma in Regulatory Affairs is an asset
- Expert knowledge of cGMP/GLP/GPP/ISO 17025, Health Canada and FDA regulations
- Significant audit experience with internal and external parties
- 5+ years of people-management experience and familiarity with leadership best practices
- Able to "hit the ground running" with minimal ramp-up/training time
- Self-starter who takes ownership of projects and issues and does is not afraid to get their own hands dirty to solve a problem, instead of strictly delegating work; knowing when to delegate as appropriate
- Genuine desire to see the business and direct reports grow and succeed.
- Must speak and write English fluently;
- Bilingualism is a strong asset;
- Must possess excellent communication skills, both written and verbal, in order to present responses to clients, prepare reports, and maintain communication with internal and external clients;
- 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;
- Must be proactive, self-disciplined, and able to demonstrate a high level of productivity with a goal-oriented approach.
- Exceptional computer skills with a high level of competence with MS Office;
- Ability to adapt to new technologies and software.
- This position will be primarily working in an office environment, sitting at a desk working on a computer. Light-intermediate lifting requirements of no more than 30 lbs. Hazardous materials are handled using established safety procedures and appropriate PPE.
- Extra hours may be required, as well as working periodic weekends and/or evenings.