Senior QC Chemist

Adare Pharma Solutions; Vandalia (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, Ohio is seeking a Senior QC Chemist to perform complex testing of intermediates and finished products, train junior staff, and ensure data integrity and regulatory compliance. You will operate advanced instruments (UV, FTIR, GC, HPLC, IC), maintain calibrations, and support audits.

The role requires a Bachelor’s degree in Chemistry or related field with 5+ years in pharma QC or related labs, and a strong grasp of cGMP/data integrity.

Qualifications

• Bachelor’s degree in Chemistry or closely related field.
• 5+ years’ experience in a Chemistry Laboratory, Quality Control or R&D in the pharmaceutical industry.
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices.
• Thorough understanding of cGMP and Data Integrity documentation requirements.

Responsibilities

• Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
• Responsible for more complex physical and chemical testing of raw material, intermediate, and finished products as described in the documented procedures to support product release and process validation protocols.
• Trains less experienced Chemists
• Demonstrate proficient ability to operate the instrument software applications, set up advanced sequences, troubleshoot software and report data while executing the higher complexity test methods that utilize instruments such as UV, FTIR, GC, and HPLC, and IC.
• As required, perform swabbing and analysis of more complex manufacturing equipment with no supervision in accordance with cGMP guidelines.
• Evaluate and maintain assigned calibrations for equipment in the laboratory as required and review the required documentation for compliance.
• Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines.
• Assist Management with writing and completion of investigation sections and product impact as required. Train others as required as it pertains to LIR/OOS procedures.
• Perform method validation and method transfer activities as required.
• Assist with customer and regulatory audits as required for Data Integrity and/or instrument file review.
• Author, revise and update laboratory test methods and Standard Operating Procedures.
• Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Peer review and/or audit others work as required for verification of GMP compliance.
• Auditing of laboratory testing data as required.
• Demonstrate consistent ability to perform testing with limited investigations and repeat analyses. Ability to accurately report test data in various formats along with advising less experienced Chemists.
• Observes all safety procedures and regulations

Skills

GMP knowledge

Quality control

Chromatography understanding

Education

Bachelor’s degree in Chemistry or closely related field

Job description

Our Business

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

Our Culture

When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?

Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

Senior Chemist

Location

Vandalia, Ohio

Summary

The Senior QC Chemist performs complex physical and chemical testing of intermediate and finished products according to written procedures and trains less experienced Chemists as required. Also responsible for testing of cleaning samples for more complex systems and more advanced instrument maintenance. Responsible for timely analytical data reporting based on project timelines.

Responsibilities

• Demonstrate advanced knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods. Perform more advanced troubleshooting/maintenance of the instrumentation.
• Responsible for more complex physical and chemical testing of raw material, intermediate, and finished products as described in the documented procedures to support product release and process validation protocols.
• Trains less experienced Chemists
• Demonstrate proficient ability to operate the instrument software applications, set up advanced sequences, troubleshoot software and report data while executing the higher complexity test methods that utilize instruments such as UV, FTIR, GC, and HPLC, and IC.
• As required, perform swabbing and analysis of more complex manufacturing equipment with no supervision in accordance with cGMP guidelines. Provide input on cleaning related issues and investigations.
• Evaluate and maintain assigned calibrations for equipment in the laboratory as required and review the required documentation for compliance. Review instrument qualification documents to support system change control actions and assist vendors during installation and PM’s.
• Investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines.
• Assist Management with writing and completion of investigation sections and product impact as required. Train others as required as it pertains to LIR/OOS procedures.
• Perform method validation and method transfer activities as required.
• Assist with customer and regulatory audits as required for Data Integrity and/or instrument file review.
• Author, revise and update laboratory test methods and Standard Operating Procedures.
• Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. Peer review and/or audit others work as required for verification of GMP compliance.
• Auditing of laboratory testing data as required.
• Demonstrate consistent ability to perform testing with limited investigations and repeat analyses. Ability to accurately report test data in various formats along with advising less experienced Chemists.

• Observes all safety procedures and regulations

Experience, Education, and Skills Required

• Bachelor’s Degree preferred, with at least 2+ years of Quality experience in a pharmaceutical or other GMP regulated industry.
• Minimum Bachelor’s degree in Chemistry or closely related field and 5+ years’ experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry
• Advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices. Good understanding of chromatography methods and problem solving.
• Has a thorough understanding of cGMP and Data Integrity documentation requirements.

Physical Demands

The employee is required to:

• stand, walk, push, pull, twist, reach overhead, and bend to the floor
• The employee may be required to wear personal protective equipment (PPE) during certain phases of the operation; such as high noise areas from machinery, exposure to a variety of chemicals, or exposure to dust, mists, and fumes.
• occasionally move items or equipment
• occasionally required to climb ladders and/or steps to reach equipment
• Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
• Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
• Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.