Lead Quality Technical Writer

Lead Quality Technical Writer

Mississauga

Regular

MERIEUX NUTRISCIENCES

As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.

If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment,
join us!

YOUR DAY TO DAY LIFE

We are looking for a Lead Quality Technical Writer in 6665 Millcreek Dr, Unit 2, Mississauga, ON L5N 5M4 CAN. Your mission will be to:

Purpose (Objective): The incumbent assists by Leading a team of Quality Technical Writers with the creation of technical reports and standard operating procedures for clients and auditing bodies to support research and development as well as for internal use.

Main activities:

Providing leadership support to and leading projects associated with the Quality Technical Writers team for the RBI account

Direct point of contact for client when dealing with Quality Technical Writers Team

Preparation of study protocols to support GLP / GMP verification and validation studies.

Review and interpretation of raw data and preparation of final reports for lab and client sign-off for submission to the FDA and / or other regulatory bodies and accrediting bodies.

Review and interpretation of verification and validation data generated to support new method development and matrix extension.

Preparation of validation data packages and all associated documentation.

Maintain and update laboratory standard operating procedures and associated documentation as needed.

Assist with local quality and method audits.

This position has the responsibilities and authority to identify departure from the quality system or test procedures and document such observations in accordance with the prescribed non-conforming system and notifies the supervisor.

Adhere to all safety policies.

Perform other related duties as needed.

Communication:

Internal Interlocutors:
Regular communication with management and laboratory staff for data-related questions and project coordination

External Interlocutors:
Regular communication with auditors and clients for specific projects

YOUR PROFILE

Knowledge:

Profile (required education/qualification and professional background):

The incumbent must have in-depth knowledge of chemistry obtained from a related degree or job experience to analyze and interpret raw data accurately.

Bachelor’s degree or relevant work experience and 5-7 years experience required, or Master’s degree and 1-2 years relevant work experience.

Required skills:

The incumbent must have strong leadership skills and have in-depth knowledge of chemistry obtained from a related degree or job experience to analyze and interpret raw data accurately. A broad knowledge of laboratory procedures and policies is necessary to ensure maintenance of appropriate quality control systems. Previous training in GLP/GMP is required along with in-depth knowledge of general knowledge of the Laboratory Information Management System is required to ensure accuracy of client data.

A general knowledge of personal computer software and basic data entry skills are needed to generate special reports and calculate quality control results. The incumbent needs strong analytical abilities to troubleshoot problems and ensure the accurate completion of analysis procedures. Developed interpersonal skills are required to build interdepartmental relationships, and foster a culture that focuses on quality. Planning skills are needed to ensure that analysis tasks are completed in a timely manner.

Excellent oral and written communication skills are required to write special reports and work with laboratory personnel on quality issues.

Management (Size and characteristics of the team(s)):
This position has no direct reports.

Howeve…