Quality Control Chemist

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare!
What can Adare offer you?
• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs
We are seeking to hire a Quality Control Chemist to join our Laboratory Operations team…
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The QC Chemist performs moderately 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 AND LEARNING OPPORTUNITIES
• Demonstrate a more 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.
• 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.
• Train other Chemists, Lab Assistants, and temporary personnel.
• 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.
• Perform cost savings and process improvement projects as required
• Observes all safety procedures and regulations
REQUIRED SKILLS AND QUALIFICATIONS
Level is commensurate with candidates’ amount of education, experience, as well as demonstrated level of knowledge and skills.
• Bachelor’s degree in Chemistry or closely related field
• 0-2 years’ experience for a Chemist I, 3-5 years’ experience for a Chemist II; experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory, in the pharmaceutical industry OR M.S. in Chemistry or closely related field and 2-3+ years of experience working in a Chemistry Laboratory, Quality Control or Research and Development Laboratory in the pharmaceutical industry.
• Moderate to advanced knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices. Good understanding of chromatography methods and problem solving.