Senior Investigations Associate
About the role
Work Schedule
Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Summary: To conduct internal, external and client Good Manufacturing Practices (GMP) audits.
Essential Functions
Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings. Participate in the site Fit and Finish Audit. Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency. Assist with ongoing guidance and training of auditors (if applicable). Assist with regulatory requests.
Manage Audit Observations and Audit CAPAs
Provide administrative support for ongoing Compliance projects. Maintain a safe working environment and report potential hazards.
REQUIRED QUALIFICATIONS
Education: Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related field Experience: Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience. Experience with SAP (an asset).
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge. Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc. Familiarity with SFLMS. Familiarity with managing GMP regulatory requests. Detail-oriented and organized, with a high degree of accuracy and thoroughness. Excellent organizational skills and ability to prioritize in a fast-paced environment. Strong written and oral communication skills. Works well and efficiently with limited supervision. Demonstrated computer proficiency with Microsoft Office programs. 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 with Patheon quality systems SOPs and Good Manufacturing Practices (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 engaging in problem-solving. Models positive thinking and is open to change, motivating the team to adapt to shift 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, and 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.
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.
Not the right fit? Search for Investigations Associate jobs in Whitby, Ontario, Canada
About Thermo Fisher Scientific
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Similar Jobs
Senior Investigations Associate
About the role
Work Schedule
Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Summary: To conduct internal, external and client Good Manufacturing Practices (GMP) audits.
Essential Functions
Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings. Participate in the site Fit and Finish Audit. Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency. Assist with ongoing guidance and training of auditors (if applicable). Assist with regulatory requests.
Manage Audit Observations and Audit CAPAs
Provide administrative support for ongoing Compliance projects. Maintain a safe working environment and report potential hazards.
REQUIRED QUALIFICATIONS
Education: Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related field Experience: Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience. Experience with SAP (an asset).
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge. Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc. Familiarity with SFLMS. Familiarity with managing GMP regulatory requests. Detail-oriented and organized, with a high degree of accuracy and thoroughness. Excellent organizational skills and ability to prioritize in a fast-paced environment. Strong written and oral communication skills. Works well and efficiently with limited supervision. Demonstrated computer proficiency with Microsoft Office programs. 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 with Patheon quality systems SOPs and Good Manufacturing Practices (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 engaging in problem-solving. Models positive thinking and is open to change, motivating the team to adapt to shift 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, and 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.
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.
Not the right fit? Search for Investigations Associate jobs in Whitby, Ontario, Canada
About Thermo Fisher Scientific
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.