Document Reviewer I

2 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

**Summary**:
Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A) and Stability reports generated in the Laboratory. Verify and confirm the integrity and traceability of all data generated and reported.

**Essential Functions**:

- Review all regular technical documents (e.g., batch testing, stability testing, method development and validation, raw materials and packaging components) and raw data generated in the Laboratory with high quality and deliver within standard time.
- Ensure the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists.
- Verify the integrity and traceability of all data generated and reported.
- Follow up with scientist/chemists to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices’ standards.
- Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
- Write/Update SOPs and initiate change control when necessary.
- Adhere to assigned schedules and standard times.
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work (as required).

**REQUIRED QUALIFICATIONS**

**Education**:
Bachelor of Science in Chemistry or related science.
**Experience**:
Minimum 2 years of previous pharmaceutical analytical development experience.

**Equivalency**_:_

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

**Knowledge,**Skills** and Abilities**:
Basic understanding the common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV) spectroscopy, and titration. Knowledge in Empower, LIMS Nugensis and Trackwise software. Excellent written and oral communication skills. Good working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements. Strong organizational skills and detail oriented. Ability to meet deadlines and prioritize. 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 to Patheon quality SOPs 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.

  • Document Reviewer Ii

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Business Title**:D**ocument Review**er**II** - QA** Issue Date: 17.SEP.2024 Revision #: 2 **Summary**: Responsible for reviewing all data, lab...

  • Documentation Coordinator

    4 weeks ago

    Whitby, Canada Thermo Fisher Scientific Inc. Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummary: Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), this includes routine filing. Manage the process for...

  • Scientist I, Research

    4 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Business Title**:Scientist I - **Development** Operations** **Summary**: Provide analytical support in the Laboratory Operations Department by following standard practices. Assist with method development and evaluation activities. Perform method validations and Research & Development (R&D) analytical testing. Make detailed observations and review, document,...

  • Scientist I

    6 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Business Title**:Scientist I - Analytical Operations (Afternoon and Weekend Shift)** **Summary**: Provide analytical support in the Laboratory Operations Department by following standard practices. Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing...

  • Scientist I

    4 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Scientist I - Analytical Operations** **This is a 12-month contract position.** **This role requires flexibility to work in the afternoon shift as well as on the weekends.** **How will you make an impact?** When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer,...

  • Scientist I

    2 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Scientist I - Analytical Operations** **This is a 12-month contract role.** **This role requires individuals to work in the straight afternoon and at weekends (when needed).** **How will you make an impact?** When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer,...

  • Scientist I

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Scientist I - Development Operations** **This role requires flexibility to work in the morning and afternoon shifts on a rotation.** **How will you make an impact?** When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our...

  • Scientist I

    3 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Scientist I -** **Development** **Operations** **This role requires flexibility to work both morning and afternoon shifts.** **How will you make an impact?** When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is...

  • Manager Document Control

    3 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Summary**: Lead the activities of the Document Control & Training team to support...

  • Document Control

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Material Handler I

    7 days ago

    Whitby, Canada STERIS Full time

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. **Join a company where the work you do makes a difference!** We are **One Team** with **One Goal**. At STERIS Applied Sterilization Technologies (AST), it’s our philosophy and our way of...

  • Manager Document Control

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionSummary:Lead the activities of the Document Control & Training team to support compliance of...

  • Documentation Coordinator

    3 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summary**: Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), this includes routine filing. Manage the process for...

  • Documentation Coordinator

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Job Posting Title: Documentation Coordinator - QA - Co-Op** **12 Month Co-Op Opportunity for an ELIGIBLE student in a Co-Op program - must maintain Co-Op eligibility until end of Co-Op work assignment.** **Summary**: Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports,...

  • Material Handler I

    2 weeks ago

    Whitby, Canada STERIS Full time

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. **Position Summary**: Responsible for the safe movement of Customer product. Safely and accurately process routine and moderately complex Customer products according to established...

  • Material Handler I

    1 week ago

    Whitby, Canada STERIS Full time

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. **Position Summary**: Responsible for the safe movement of Customer product. Safely and accurately process routine and moderately complex Customer products according to established...

  • Contaminated Lands Expert

    7 hours ago

    Whitby, Canada WSP Global Inc. Full time

    About the RoleYou will support our clients' management of excess soil from their construction projects, primarily related to our Contaminated Lands services, including Phase I ESAs, Phase II ESAs and/or site remediation to support Risk Assessments and Record of Site Conditions (Ontario Regulation 153/04). You will also supervise and coach junior colleagues...

  • Scientist I

    4 days ago

    Whitby, Canada Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Scientist I

    1 week ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Work Schedule** Second Shift (Afternoons) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Summary**: Provide analytical support in the Laboratory Operations Department by following standard practices. Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial...

  • Scientist Ii

    2 weeks ago

    Whitby, Canada Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Business...