Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
Responsible for reviewing all data, lab notebooks, and completed Certificates of Analysis (C of A)and Stability reportsgenerated in theLaboratory Verifyand confirm the integrity and traceability of all data generated and reported.
This position is M-F 3:00pm-11:30m.
Essential Functions:
Review all regular technical documents (e.g., batch testing, stability testing,methoddevelopment andvalidation, rawmaterialsand packaging components) and raw data generated in theLaboratorywith high quality and deliver within standardtime
Release Raw Material and Packaging Components in SAP
ReleaseofProductCertificate ofAnalysisusing applicableLIMS software
Ensurethe test methods,protocolsand Standard Operating Procedures (SOPs) have been followed bythe scientistschemists.
Verifythe integrity and traceability of all data generated and reported.
Follow up with scientist/chemists to ensure that all necessary corrections are correctedin accordance withGood Manufacturing Practices’ standards.
Notifydepartment supervisor/manager regarding omissions, incomplete testingresultsor other irregularities.
Write/Update SOPs and initiate change control when necessary
Adhere toassigned 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 3 years ofpreviouspharmaceutical analytical development experience.
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge,Skillsand Abilities:
Basicunderstandingthe common analytical technologies (e.g., High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (UV)spectroscopy, and titration. Knowledge in Empower, LIMSNugensisandTrackwisesoftware Excellent written and oral communication skillsGood working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH)and United States Food & Drug Administration (FDA) requirementsStrong organizational skills and detail oriented. Ability to meet deadlines and prioritize. Demonstrated computerproficiencywith Microsoft Office programsProficiencywith the English Language.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members,modellingpositive team principles and partnering to meet project and departmentalobjectives Carry out all duties within strict compliancetoPatheon qualitySOPsand Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systemsin order tomaintaina smooth and efficient workflow (visual management, scheduling systems, etc.).Be client and patient conscious at all timesUnderstand Key Performance Indicators andstrive to improve the performance of the team byidentifyingareas 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. Proactivelyidentifyareas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner Consistentlystrives to improve skills and knowledge in relatedfield
Physical Requirements:
Light physical effort and fatigue. Walks,sitsor stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typicallylocatedin a comfortable indoor areaThere may be regular exposure to mild physical discomfort from factors such as dust, fumes orodours, temperature extremes, loud noise, strong drafts, or bright lights.Use of Personal Protective equipment may berequiredand may include any of the following: safety glasses, safety shoes, lab coat, gloves,hair net, beard cover,safety apron,respiratoronoccasionally
Compensation
The estimated annualized pay range for this position in Ontario is $50,800.00–$76,150.00.
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.
