Senior Investigations Associate

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Title: Senior Investigations Associate

Summary:
Initiate and lead/coordinate the investigation of Customer Complaints and Incoming Material Deviations. Work with the appropriate departments related to Customer Complaints and Incoming Material Deviations. 
Review and revise specifications on Analytical Release Forms (ARFs) and Certificates of Analysis (CofAs) for Raw Material, Bulk and Finished Product.

Essential Functions: 

• Investigates and generates reports for customer complaints and incoming material deviations, reviews ​ executed batch records, logs complaint samples and maintains database.

• Generate monthly and quarterly performance matrix and reports related to Customer Complaints.

• Log Complaint Reports and Samples and update/maintain database.

• Review, update and maintain indexes.

• Review and perform compendial updates.

• Review Change Controls, prepare and revise ARFs and CofAs in accordance with client and material  requirements.

• Provide training and mentoring for the Quality Investigator - Complaints

• Maintain a safe working environment and report potential hazards.

• Provide support to Project Leaders within Quality (as required). 

• Perform alternating or rotating shift work (as required).

REQUIRED QUALIFICATIONS
Education:

• Bachelor of Science (B.Sc.) in chemistry, biology, life sciences or a related field.

Experience:

• Minimum 5 years experience in the pharmaceutical industry.

Equivalency:

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

Knowledge, Skills and Abilities:

• Strong interpersonal skills. Extensive knowledge of Good Manufacturing Practices, Standard Operating 

• Procudures and Corrective Action Preventative Action (CAPA). Excellent organizational skills with proven  ability to prioritize when timeline conflicts exist.

• Ability to problem solve and troubleshoot. Detail oriented. 

• Proficient Microsoft skills (Word, Excel, PowerPoint). Proficiency with the English language (oral and  written). 

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 Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Effectively engage in and adhere to departmental systems 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. Model 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 exposure to mild physical discomfort from factors such as dust, fumes or odors, 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 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.

Compensation