Quality Laboratory Chemist - 2nd Shift
Role Overview
The Quality Control Chemist supports laboratory operations through analytical testing in a regulated manufacturing environment.
The position involves product and material testing, procedure compliance, documentation, troubleshooting, and continuous laboratory improvement.
The posting describes both Chemist I and Chemist II qualification profiles; it does not specify which level applies to this opening.
Key Skills for This Role
Full Job Posting
Position summary
The Quality Control Chemist supports laboratory operations through analytical testing in a regulated manufacturing environment.
The position involves product and material testing, procedure compliance, documentation, troubleshooting, and continuous laboratory improvement.
The posting describes both Chemist I and Chemist II qualification profiles; it does not specify which level applies to this opening.
Schedule
- The schedule is Monday through Thursday evenings and Friday afternoon/evening; exact hours are not specified.
Responsibilities
- Test raw materials, in-process and stability samples, and finished products using approved procedures.
- Execute analytical methods, document activities and results, review data, and support OOS, OOT, and atypical result investigations.
- Assist with training; collaborate across quality, manufacturing, technical operations, and regulatory teams.
- Follow safety, cGMP, data integrity, and quality system requirements; maintain and calibrate laboratory equipment.
- Operate analytical instruments and support deviations, CAPAs, change control, method implementation, and process improvements.
- Maintain compliance, communicate testing progress and issues, and complete assignments on time.
Preferred technical experience
- Hands-on experience with several techniques or instruments is sought, including HPLC, GC, FTIR, UV/Visible spectroscopy, dissolution testing, wet chemistry, titration, balances, and general laboratory equipment.
- Empower chromatography software experience is highly preferred, including data acquisition, integration, review, reporting, and troubleshooting.
- Chromatographic data review, electronic laboratory documentation, and audit-ready recordkeeping experience are highly preferred.
Qualifications
- A B.S. in Chemistry or a related scientific discipline is specified for both Chemist I and Chemist II.
- Chemist I: at least 2 years of analytical laboratory experience is preferred; FDA-regulated and cGMP-compliant experience is strongly preferred.
- Chemist II: 5–8 years of analytical laboratory experience in regulated manufacturing, FDA-regulated cGMP quality control experience, and independent method execution and investigation support are required.
- Preferred experience includes regulated industries, stability and release testing, raw material testing, OOS/OOT investigations, Good Documentation Practices, inspections, and quality systems.
- Physical duties include standing and walking for extended periods, bending, reaching, squatting, climbing stairs, and lifting, pushing, or pulling up to approximately 50 pounds.
- Strong analytical and troubleshooting abilities, attention to detail, documentation practices, communication, and ability to manage priorities are desired.
Work environment
- Laboratory work in a regulated manufacturing environment includes physical activity and operation of laboratory equipment.
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