Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Summary:

Responsible for coordination and management of Lab Support activities. Work in collaboration with members of Laboratory Operations Department and other Departments as required. With an emphasis on internal customer service the role plays an essential function towards enabling the Laboratory Operations Department to provide an outstanding customer service experience.

Essential Functions:

• Supervise, coach and develop 6-14 Lab Support staff in the performance of their duties.

• Develop direct report team through goal setting, performance management with regular review i.e. 1 on1 meetings.

• Supervise the daily activities for Lab Support, ensuring all activities are completed as required per site, regional or global Standard Operating Procedures (SOP’s).

• Ensure all Lab Support activities is completed to the highest quality standards.

• Ensure activities follow Good Manufacturing Practices (GMP) with supporting documentation that is in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate).

• Direct and manage Purchasing, Laboratory Kanban Systems, Glassware Washing, stock scientific glassware, restocking of lab supplies, Lab Systems, reference standards.

• Direct and manage microbiology lab activities such as labelling and storing (in fridges or autoclaves), glassware washing and collecting, biohazardous waste disposal.

• Ensure availability of AQPIC’s.

• Actively engage in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies.

• Influence and motivate staff to consistently meet deadlines set forth on the daily operational scheduling / huddle visual management boards

• Support laboratory investigations and deviations, identifying root causes and enacting effective Corrective Action Preventative Actions to improve overall laboratory performance % Right First Time.

• Ensure GMP Documentation are filed, scanned and organized.

• Work with cross-functional teams’ in production, quality assurance, regulatory, commercial, project management, etc. to support product campaigns.

• Monitor and respond to internal and external customer requirements to ensure complete customer satisfaction.

• Provide Manager with a daily recap for departmental awareness.

• Participate in goal setting and conducts performance reviews for direct reports.

• Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures.

• Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advises staff on administrative policies and procedures.

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science in Chemistry or related science.

Experience:

Minimum 5 years’ experience in quality control/analytical development within the pharmaceutical industry

Previous Supervision and/or leadership and training experience

Equivalency*:*

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills**,** and Abilities:

Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs. Excellent problem-solving skills and the ability to apply a logical approach to solving scientific problems. Excellent interpersonal and communication skills (both oral and written). Excellent presentation skills to present information to customers, clients, and other employees to provide guidance in scientific and regulatory issues. Demonstrated leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. Proficiency in Microsoft Word, Excel, Access, MS Project. Proficiency with the English language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.