Validation Chemist

Résumé du poste

The Validation Chemist develops and validates analytical methods for new and existing products while ensuring compliance with cGMP and regulatory standards. They also manage method transfers to the Quality Control department and oversee laboratory equipment validation and performance monitoring.

Détails du poste

The Opportunity We are seeking a Validation Chemist to join our Quality team. In this role, you will develop, verify, validate, and transfer analytical methods that support new product development, quality control, and regulatory compliance. You will play a key role in bringing analytical testing in-house, implementing modern technologies, and ensuring testing methods deliver accurate, reliable results. Working closely with cross-functional teams, you will support method development, equipment qualification, troubleshooting, and continuous improvement initiatives while helping reduce our environmental footprint through innovative laboratory practices. What You'll Do Develop, verify, and validate analytical methods for new and existing products. Support method development for product testing, stability studies, and routine quality control analysis. Create training materials and facilitate method transfers to the Quality Control team. Manage multiple validation projects simultaneously while meeting timelines and business priorities. Troubleshoot analytical methods, instrumentation, and product-related testing challenges. Validate new laboratory equipment, including protocol development, execution, reporting, and ongoing performance monitoring. Prepare accurate analytical reports and maintain data integrity using approved procedures, SOPs, LIMS, and cGMP requirements. Collaborate with Quality, R&D, Operations, and other departments to execute validation activities and corrective actions. Support change control processes, including impact assessments and implementation activities. Maintain documentation required for quality systems and SR&ED submissions. Ensure compliance with all safety, quality, and regulatory requirements. Travel to other company sites for training or project support as needed. What You'll Bring Education & Experience Bachelor of Science in Analytical Chemistry or a related scientific discipline. Minimum 2 years of experience using analytical instrumentation such as HPLC, LC-MS, ICP, or similar technologies. Minimum 1 year of method validation experience. Experience working in a GMP-regulated pharmaceutical, nutraceutical, or related manufacturing environment. Experience with solid dosage forms is considered an asset. Technical Skills Strong understanding of analytical chemistry principles and laboratory practices. Experience with chromatography data systems and analytical software. Familiarity with Thermo Chromeleon™ CDS is preferred. Proficiency with Microsoft Office applications and Laboratory Information Management Systems (LIMS). Knowledge of software and equipment validation requirements, including: 21 CFR Part 11 Annex 15 (EudraLex) GAMP Guidelines Relevant GMP requirements Personal Attributes Strong analytical thinking and problem-solving skills. Excellent written, verbal, and presentation communication skills. Ability to work independently and collaboratively within a team environment. Strong organizational skills and the ability to manage multiple priorities. Effective relationship-building skills and a collaborative mindset. Why Join Factors Group? At Factors Group, you'll have the opportunity to contribute to innovative health and wellness products while working in a collaborative, science-driven environment. We are committed to continuous improvement, sustainability, employee development, and maintaining the highest standards of quality. Application Information This position is open to all qualified applicants legally entitled to work in the country where the position is located. Applications will be reviewed as they are received, and the posting will remain open until a suitable candidate pool has been identified. Internal applicants will receive priority consideration during the first five business days of the posting period. We thank all applicants for their interest; however, only those selected for further consideration will be contacted. This position is open to all qualified applicants who are legally entitled to work in the country in which this job is located. Only electronic applications can be accepted. This position will close when a competitive candidate pool has been identified. We thank you all for your applications and a member of our team will contact you soon. All the best! All Internal applicants will be given priority for consideration for the first five business days that this position is posted. After that five days, Internal applicants will be considered along with all other applicants; however, are guaranteed at minimum a call from the Talent Acquisition team.

Ce que vous ferez

The Validation Chemist develops and validates analytical methods for new and existing products while ensuring compliance with cGMP and regulatory standards. They also manage method transfers to the Quality Control department and oversee laboratory equipment validation and performance monitoring.

Exigences

Candidates must hold a Bachelor of Science degree in Analytical Chemistry or a related field. The role requires at least 2 years of experience with analytical instrumentation and 1 year of specific validation experience within a GMP pharmaceutical environment.

Compétences indiquées

• Assurance qualité · Souhaitée
• Analyse de données · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Analytical Chemistry
• HPLC
• LC-MS
• ICP
• Method Validation
• Method Development
• cGMP
• LIMS
• Thermo Chromeleon
• Troubleshooting
• Data Analysis
• Technical Writing
• Regulatory Compliance
• Equipment Calibration
• Quality Control
• Quality Assurance
• Current Good Manufacturing Practices (cGMPS)
• Developing Training Materials
• Order Management
• Business Metrics
• Product Analysis
• Laboratory Equipment
• Talent Management
• Ability To Meet Deadlines
• Analytical Method
• Change Control Process
• Title 21 Of The Code Of Federal Regulations
• Quality Management Systems
• Research
• Good Manufacturing Practices
• Calibration
• Change Control
• Change Requests
• Chromatography Software
• Communication
• Development Studies
• Instrumentation
• English Language
• Standard Operating Procedure
• Leadership
• High-Performance Liquid Chromatography
• Interpersonal Communications
• Problem Solving
• Laboratory Information Management Systems
• Liquid Chromatography Mass Spectrometry
• Microsoft Office
• Order Management Systems
• Performance Metric
• Pharmaceuticals
• Presentations

Domaines d’emploi

• Science & Research
• Manufacturing
• Healthcare
• QA/QC Chemist
• Quality Control Analyst
• Physical and Engineering Science Technicians Not Elsewhere Classified
• Quality Control Analysts
• Life, Physical, and Social Science Technicians, All Other