QC 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 QC 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:

• Create and execute qualification, validation, and summary protocols/documents
• Assist with identifying and developing validation programs and related quality systems
• Perform and assist with validation activities
• Communicate with internal stakeholders to ensure timely completion of reports and corrective action items
• Develop and validate analytical methods for new/existing products that are suitable for use in development studies, stability studies, and routine product analysis
• Perform other validation activities (e.g., process, equipment, computer systems, cleaning) to ensure adherence to the Validation Master Plan
• Create training materials to assist in method transfer to everyday use
• Troubleshoot performance issues with products performed by validated methods
• Lead project teams to accomplish multiple validation efforts simultaneously
• Perform wet chemistry, dissolution, ultraviolet (UV) and high-performance liquid chromatography (HPLC) routine analyses
• Perform laboratory instrument validations (IQ/OQ/PQ) and calibrations
• Report all quality issues to department leadership
• Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
• Strictly adhere and observe all safety policies as outlined in the company policies and training sessions
• Other duties as assigned

Requirements:

Technical

• Completion of a Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or related science
• Minimum 2 years of HPLC, LC-MS, ICP and 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, chromatography software, and laboratory information management system (LIMS). Preference is given to those familiar with Thermo Chromeleon™ CDS and StarLIMS.
• An equivalent combination of education and experience may be considered

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