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.) Job Description Division/Site: Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. Discover Impactful Work: Initiates and leads/coordinates the investigation and works with the appropriate parties related to Deviation Reports (DRs). The position will respond to both Packaging & Processing deviations. This position is also responsible for trending issues, especially as it relates to gaps that are identified in root cause investigations. Day in the Life: Initiate and lead operational investigations into deviations with appropriate cross functional parties. Perform root cause analysis of deviations through the use of RCA tools to identify the root cause. Perform technical writing of investigations. Evaluate the thoroughness of investigations and determined root cause. Propose Corrective Actions Preventative Actions (CAPAs) to ensure root cause of investigations are addressed and prevent recurrence of the event. Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements. Track, trend, and monitor metrics for deviation investigations and related processes to identify trends. and associated actions to mitigate risks and drive performance. Ensure on time closure of assigned Investigations, CAPAs, Change Controls. Support continuous improvement of the Investigation process through Practical Process Improvement (PPI) concepts. Assist with regulatory / client audits as required. Maintains a safe working environment and reports potential hazards. Performs alternating or rotating shift work (as required) Keys to Success: Education: College/Technical School diploma in pharmaceutical manufacturing, science or related field. Experience: Minimum 2 years of manufacturing experience in pharmaceutical, food or cosmetic industry, with knowledge of batch packaging principles. Previous experience in technical or scientific writing an asset. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, and Abilities: Strong interpersonal skills. Understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA. Good organizational skills with proven ability to prioritize when timeline conflicts exist. Ability to problem solve and troubleshoot. Ability to carry out investigations in a collaborative manner with production staff and to effectively interact with internal and external suppliers and clients. Proficient Microsoft skills (Word, Excel, PowerPoint). Proficiency with the English language (oral and written). 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. Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement OTHER Relocation assistance is NOT provided Must be legally authorized to work in Canada Must be able to pass a comprehensive background check Compensation The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00. 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. 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.