Overnight QC Chemist

Company Overview

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We provide manufacturing, packaging, and research and development services to a range of clients, from emerging biotech firms to established pharmaceutical companies. Our mission, “Transforming Drug Delivery – Transforming Lives,” reflects our focus on delivering lifesaving medicines in formats that are easier for patients such as infants and the elderly.

Our culture emphasizes collaboration, client‑centricity, and continuous learning. Employees work across diverse backgrounds toward a common purpose, supported by experienced leadership and internal development opportunities.

Summary

The Quality Control Chemist performs moderately complex physical and chemical testing of intermediate and finished products according to written procedures, including testing of cleaning samples and advanced instrument maintenance. The role is responsible for timely analytical data reporting based on project timelines.

Responsibilities

• Demonstrate knowledge of various test methods and instrument analysis techniques; be proficient with all sample types and test methods.
• Perform advanced troubleshooting and maintenance of instrumentation.
• Conduct complex physical and chemical testing of raw material, intermediate, and finished products to support product release and process validation protocols.
• Operate instrument software applications, set up advanced sequences, troubleshoot software, and report data for instruments such as UV, FTIR, GC, HPLC, and IC.
• Perform swabbing and analysis of complex manufacturing equipment in accordance with cGMP guidelines; provide input on cleaning‑related issues and investigations.
• Evaluate and maintain assigned equipment calibrations; review documentation for compliance.
• Review instrument qualification documents, support system change control actions, and assist vendors during installation and preventive maintenance.
• Investigate Out‑of‑Specification (OOS), Out‑of‑Trend results, and deviations per cGMP guidelines; assist management with investigation documentation and product impact assessments.
• Train others on LIR/OOS procedures as needed.
• Perform method validation and method transfer activities.
• Assist with customer and regulatory audits for data integrity and instrument file review.
• Author, revise, and update laboratory test methods and Standard Operating Procedures.
• Accurately maintain notebooks and files compliant with GMPs and internal SOPs.
• Peer‑review and audit others’ work to verify GMP compliance; audit laboratory testing data as required.
• Consistently perform testing with limited investigations and repeat analyses; accurately report test data and advise less‑experienced chemists.
• Observe all safety procedures and regulations.

Experience, Education, and Skills Required

• Bachelor’s degree in Chemistry or a closely related field.
• Working knowledge of laboratory procedures, equipment, instrumentation, safety procedures, and laboratory practices.
• Good understanding of chromatography methods and problem‑solving skills.
• Thorough understanding of cGMP and Data Integrity documentation requirements.

Physical Requirements

• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Wear personal protective equipment (PPE) as required in high‑noise areas, or when exposed to chemicals, dust, mists, or fumes.
• Occasionally move items or equipment and climb ladders or steps to reach equipment.
• Read precision measuring equipment, machine dials, gauges, and thermometers; observe fine details using a microscope.
• Detect odors of unacceptable compounds or mixtures; possess steady hands and good coordination for handling delicate laboratory instrumentation.

Benefits

• Medical, dental, and vision coverage.
• Retirement plan with company match.
• Paid time off and company holidays.
• Tuition reimbursement with no waiting period.
• Life insurance and pet insurance.
• Flexible Spending Accounts (medical and dependent care).
• Disability coverage.