Description

Position Summary:

The QC Chemist will be responsible for performing Quality Control Laboratory Testing activities in a fast paced environment, and perform technical tasks that support production operations; routine and non-routine chemical testing of raw materials, bulk products, finished goods, stability samples, validation samples; and method transfer procedures.

Reports to:QC Laboratory Supervisor

Functional Responsibilities:

• Test method development: research test method options for new products and develop the test methods to meet requirements.
• Complete special projects as assigned by the lab manager within the specified time line.
• Troubleshoot software and hardware issues with analytical instrumentation.
• Author test method validation protocols and prepare final validation packages.
• Execute testing per approved test method validation protocols.
• Prioritize work load and schedule testing to meet production and distribution plans.
• Perform batch release and finished good testing to ensure Quality Control on all manufactured goods.
• Perform stability testing and assist with maintenance of the stability program for all products.
• Conduct analysis on raw ingredients using internal test method/specifications and USP criteria.
• Maintain the raw ingredient qualification and annual testing program per the SOP.
• Complete the required preventative maintenance on instrumentation, and schedule calibrations of laboratory equipment.
• Perform Out-of-Specification investigations and document findings in a report.
• Conduct investigative testing on products per our consumer complaint procedure.
• Support regulatory inspections by the FDA.

Required Experience, Desired Skills & Qualifications:

• Understand test method validation regulatory guidelines and Industry standards.
• Previous experience with new test method development is expected.
• Strong verbal and written communication skills.
• Proficient with GC, HPLC, FT-IR analytical test methods.
• Previous experience working in a cGMP/GLP environment is required.
• Previous experience with raw ingredient testing.
• Computer knowledge of data collection and spreadsheet software, practical experience with ERP systems, and strong research resources.
• Multitasking and time management skills are critical for this position because of the fast-paced environment and the varied job tasks that are part of the position.

Educational Qualifications:

• Bachelor of Science degree in Chemistry is required, or minimum of 10 years applicable work experience as a chemist is required.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to sit or stand; use hands, handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear.

• The employee must be able to lift and/or move up to 30 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Ability to bend or reach throughout the workday.
• Employee must be able to sit or stand for up to 10 hours in a workday.
• Ability to function in highly stressful situations.

Environmental Requirements:

This position is required to be onsite full time. The work environments described here are representative of those an employee encounters while performing the essential functions of this job onsite. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

Qualifications