QC & QA (Saly) - Validation Chemist

Organizational Summary

Factors Group of Nutritional Companies Inc. is a leading manufacturer of nutritional supplements and other health-building products. We are dedicated to enhancing the wellbeing of our customers through research, development and delivery of effective nutritional products. It is our mission to contribute to the lives of our customers, employees, suppliers and the communities we serve, in a cooperative and sustainable manner.

Job Summary

The Validation Chemist develops and validates new methods to bring analysis in-house and change existing methods to accurately analyze new formulas through either verification or validation activities. The Validation Chemist supports method transfer to general QC analysis through the development and administration of training materials, in addition to troubleshooting analysis difficulties. The Validation Chemist does all this in the context of reducing Factors Group’s environmental footprint by using modern technologies whilst striving for methods to provide the most accurate results.

Job Responsibilities

• Develop and validate analytical methods for new/existing products that are suitable for use in development studies, stability studies, and routine product analysis and meet requirements for AOAC submission.
• Create training materials to assist in method transfer to Quality Control area.
• Balance multiple validation projects simultaneously to accomplish their completion efficiently and quickly.
• Ensure supplies, instrumentation and equipment are available to meet test schedules. Be responsible for material / order management within the area
• Perform QC testing activities to support rush work and company objectives, includes troubleshooting of method performance for product change, revisions, and equipment performance issues.
• Validate all new laboratory equipment including creation of protocols, summary reports, and participation in ongoing calibration / verification efforts.
• Provide accurate, neat, reliable, complete analysis reports, including result entry in computerized reports or Laboratory Information Management System, by following approved Work Procedures (WP) and Standard Operating Procedures (SOP), Analytical Methods (AM), and current Good Manufacturing Practices (cGMP)
• Document activities and supplies used during research for SR&ED submission.
• Coordinate with other functional departments to plan, execute and complete validation activities including reports and corrective action items to ensure timely completion.
• Use of company QMS systems for document creation, revision, review, approval, and retention.
• Support change control process through: initiation of change controls (CC) and document change requests (DCR), review of CC for validation impacts, performance of action items, and provision of additional data.
• Use of chromatography software Method Validation run templates to facilitate efficient completion of pre-validation and method development activities.
• Support other validation efforts as required.
• Travel to other sites (including out of country) for meetings and trainings as required
• Strictly adhere and observe all safety policies as outlined in the company policies and training sessions
• Development of equipment monitoring through performance metrics to limit unplanned downtime.
• Create, revise, and execute systems for SR&ED documentation purposes.
• Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
• Other duties as assigned

Requirements

Technical

• Completion of a Bachelor of Science degree in Analytical Chemistry or related science
• Minimum 2 years of HPLC, LC-MS, ICP or other instrumentation experience
• Minimum 1 year of previous validation experience
• GMP industry experience in pharmaceutical manufacture of solid dosage forms in a hands-on technical/analytical role
• Strong proficiency with Microsoft Office suite of applications, and familiarity with laboratory information management system (LIMS).
• Strong proficiency with chromatography software. Preference is given to those familiar with Thermo Chromeleon CDS.
• Provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements including 21 CFR parts 11, Annex 15 (Eudralex), GAMP and other guidance documents, as appropriate to the business needs

Attributes

• Excellent communication skills (verbal, written and presentation) in English
• Strong analytical laboratory and problem-solving skills
• Strong interpersonal skills, with ability to collaborate productively with individuals at all levels of the organization
• Ability to work both independently and within in a team
• Ability to prioritize activities in order to meet deadlines and changing priorities

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.