Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description How will you make an impact? Support and ensure adherence to established Standard Operating Procedures (SOPs) for conducting and generating the Annual Product Review (APR) report. Function as a liaison between several internal departments with the intent to gather relevant data. Support the compilation of product data for the review period with the objective of verifying the consistency of existing process, the appropriateness of current specifications, highlighting any trends and identifying both product and process improvements for the drug product. Provide support for various activities within the Quality Systems department. Provide training and support to Annual Product Review coordinators and Annual Product Review Associates. Assess changes to Regulatory, corporate and industry standard to determine site impact. What will you do? Compile and review drug product data including batches manufactured, quantity, test results, manufacturing and laboratory investigation, product quality related complaints, stability data, change controls, specification changes, validation activities, etc. Perform administrative tasks of data entry, generates trending reports and statistical data analysis for Annual Product Reports. Work with clients to address issues related to Annual Product Reviews to complete reports in a timely manner. Provide administrative support for various internal, external and regulatory requests. Provide support for other quality systems within the Quality Systems Department, as needed. (e.g. GVault System, Change control approvals, MBR approvals, Data Integrity, eDMS, GTW and LMS support) Provide training and technical expertise to other APR Coordinators and APR Associates. Assess changes to Regulatory, corporate and industry standard to determine site impact. Participate in improvement events on behalf of the annual product review team (as required) Provide ongoing suggestions for improvements for quality and efficiencies in performance and completion of change controls. Provide support for other quality systems within the Quality Systems Department, as needed. (eg. eDMS, GMP Training, change control approval, master batch record approval). Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) How will you get here? Education: College/Technical School Diploma in relevant field Bachelor of Science (B.Sc.) an asset. Experience: Minimum 4 year of previous related experience in the pharmaceutical/food/cosmetic industry, preferably in a QA function. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, and Abilities: Familiar with SOPs and Good Manufacturing Practices (GMPs). Detail oriented with a high degree of accuracy and thoroughness. Demonstrated computer proficiency with Microsoft Office programs. Intermediate Excel proficiency - data entry and plotting data for statistical graphs. Excellent organizational skills and ability to prioritize in a face-pace environment. Works well and efficiently with limited supervision. Strong written and oral communication skills. 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 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 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. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
