Job Title: QC Chemist
Location: South Milwaukee, WI
Industry: Manufacturing (consumer products)
Status of Hire: direct placement; permanent
Pay: 64-78K
Hours: 7am-5pm M-Th and ½ day Fridays 8am-12pm with flexible hours (within reason).
On-site presence required (not hybrid/remote)
Reports to: QC Lab Supervisor
Position Summary:
The QC Chemist II 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.
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 timeline.
- 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:
- Bachelor of Science degree in Chemistry is required, or minimum of 10 years applicable work experience as a chemist is required.
- This position is required to be onsite full time.
- 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.