QC & QA (Saly) - Validation Chemist

Factors Group of Nutritional Companies•Kelowna, BC

About The Position

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.

Requirements

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
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

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