Responsibilities and Duties :
Ensures that all data generated conforms to the methods, the specifications, the SOPs and good laboratory practices.
- Reviews documentation generated by the analyst;
- Ensures that the laboratory notebook contains all steps and information inherent to the analysis;
- Ensures that the laboratory notebook complies with GMP standards and current SOPs;
- Ensures that spreadsheets, sequences, laboratory reports, and other documents present accurate information;
- Verifies the integration of chromatograms;
- Checks the usage logs of analytical instruments;
- Ensures that the performance verification of the instrument used is valid;
- Ensures that the results meet the specifications when available;
- Documents irregularities and verifies the content of validation reports and deviation sheets,
- Ensures the consistency of results considering the project history;
- Prepares documents (result files, summaries, etc.) and may send them to clients;
- Acts as a resource person, supports laboratory employees in performing their tasks such as writing investigation reports;
- Communicates and explains detected errors to the employee.
Engages in continuous improvement :
- Makes sure to communicate to all employees the basics of adequate documentation;
- Evaluates the quality of the projects submitted by the employee and provides a report to the supervisor;
- Participates in the standardization of revision within the department;
- Suggests ideas for improvement in order to minimize review time.
Skills, knowledge and abilities :
- Supports a workload with accuracy and within prescribed deadlines;
- Able to complete a given task within tight deadlines;
- Able to complete several concurrent projects;
- Handles frequent priority changes;
- Completes work with minimal supervision;
- Deals with lack of information, resolves minor issues independently;
- Plans and organizes time and work effectively;
- Sets priorities, develops action plans;
- Capable of interpretation;
- Identifies irregularities, makes relevant observations;
- Contributes to team functioning;
- Identifies development opportunities and provides improvement solutions, participates in improvements, is attentive to others, offers help and contribution, participates in peer problem-solving;
- Takes quick action in urgent situations;
- Able to establish contacts with others;
- Good listener, respectful, constructive in comments;
- Knowledge and proficiency in LabX, Empower, LIMS, Microsoft Office software;
- Knowledge of the pharmaceutical field, mastery of GLP regulations;
- Positive and professional attitude;
- Effective oral and written communication.
Il y a 10 jours