Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Summary: Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, support and assistance to the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Work with Engineering groups to maintain MBR templates. Lead and participate in improvement initiatives to support the site as well as improve processes within the Technical Writing department. Act as subject matter expert in relation to revising and creation of master batch records and labels, as well as change controls. Essential Functions: Master Batch Records (MBR) Generation Understand all requirements to generate and develop all master batch records working closely with Commercial / Pharmaceutics & Process Technology departments, Technical Project Leaders and Project Managers in the generation and approval of Master Batch Records (MBR’s). Update and maintain master records and directories ensuring that records are updated as per current requirements. Follow production schedule requirements. Prepare planned deviations, execute action items to facilitate manufacturing and packaging activities. Develop bill of materials for new products. Verify accuracy of bill of materials and item master information that has been entered into the computer system as it applies to packaging components. Create and ensure the most current approved Shipper Labels and Shelf Pack Labels are located in the “master” directory. Generate and update Shipper Fill Diagram and Pallet Pattern as per packaging instructions. Coordinate the official sign off circulation and implementation of Master Manufacturing and Packaging Records. Control, compile and maintain Product Technical Files for all products. Control access to MBR’S. Provide current Master Records to Planning and maintain the MBR data base. Generate and revise Change Control to master records and generation of new Master Records. Issue batch records ensuring all planned deviations noted as required. Assist Technical Project Leaders with batch record set-up and other Manufacturing and Packaging issues. Attend key project team meetings, client teleconferences and on-site visits. Assist Technical Project Leaders in the generation of protocols, reports and assessments. Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: College Diploma in Science/Technical related field (Food or Drug) B.Sc. an asset Experience: Minimum of 3 years related experience with report writing and batch record preparation preferred. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Strong written and oral communication skills. Good technical skills and capability to understand different manufacturing and packaging processes. Well organized and detail oriented. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Experience in managing multiple priorities. Self motivated and able to work independently. Proficiency using MS Office, particularly Microsoft Word and Excel. 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 systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively 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. 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. 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.
