Position Summary
A pharmaceutical quality organization is seeking a QC Chemistry Associate (Level I or II) to support analytical testing of compounded and manufactured products distributed nationwide. This role performs routine laboratory analyses, prepares reagents, follows established test methods, and ensures compliance with quality and regulatory standards. The Associate will operate laboratory instrumentation, document results accurately, and maintain a clean, safe working environment.
Essential Responsibilities
Laboratory Testing & Analysis
- Routine sample testing — Perform qualitative and quantitative analyses under general supervision.
- Assay execution — Conduct testing for in‑process materials, finished products, raw materials, and routine samples.
- Wet chemistry procedures — Execute pH, specific gravity, titrations, viscosity measurements, and similar tests.
- Instrument operation — Follow equipment check procedures, troubleshoot issues, and report malfunctions promptly.
Documentation & Compliance
- cGMP adherence — Follow SOPs, GLPs, and regulatory requirements.
- Data recording — Compile and review test data for accuracy and specification compliance.
- Regulatory awareness — Support documentation needs for audits and inspections.
Laboratory Maintenance
- Equipment upkeep — Standardize and maintain laboratory instruments.
- Work area cleanliness — Maintain clean benches, shelving, and floors.
- Waste handling — Collect and dispose of laboratory waste per established guidelines.
Professional Conduct
- Team collaboration — Work independently or as part of a team within defined procedures.
- Professional communication — Interact respectfully with internal and external partners.
- Quality culture — Demonstrate behaviors aligned with organizational values and quality expectations.
Required Qualifications
- Bachelor’s degree in a Life Sciences discipline or equivalent.
- Minimum 1 year of laboratory or QC experience.
- Ability to perform testing with high accuracy and reproducibility.
- Strong attention to detail and effective written/verbal communication.
- Proficiency with Microsoft Office.
- Demonstrated ability to follow detailed laboratory instructions.
Knowledge & Skills
- Analytical techniques — Understanding of good lab practices, cGMP, GLP, SOPs, USP, and FDA expectations.
- Instrument experience — Familiarity with UPLC, HPLC, GC/MS, ICP/MS, and LC/MS.
- Strong organizational, interpersonal, and time‑management skills.
- Ability to prioritize and meet deadlines in a fast‑paced environment.
- Detail‑oriented with the ability to multitask effectively.
Physical Requirements
- Ability to stand or sit for extended periods.
- Ability to reach, grasp, stoop, and perform repetitive motions.
- Ability to lift, push, or pull up to 40 lbs.
- Occasional travel may be required.
Work Environment
- Indoor laboratory setting with controlled temperatures.
- Use of protective lab attire.
- Exposure to moderate noise levels.
- Work performed in a confined lab area.