Quality Control Supervisor

Hartmann Young Limited; City of Albany (NY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Hartmann Young Limited in Albany, NY is seeking a Quality Control Supervisor to lead the analytical testing of raw materials, in-process samples, finished APIs, and project samples. You will oversee QC laboratory operations and manage a team of QC chemists, ensuring safety and quality standards are met.

The role requires a Bachelor’s degree in Chemistry or related field, at least 5 years in a cGMP environment with chromatography, and 2+ years in supervision.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field.
• Minimum 5 years’ experience in a cGMP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation, including a minimum of 2 years supervisory experience.
• Demonstrated ability to effectively utilise team resources.
• Expert in cGMP, USP, EP and FDA regulations.
• Strong oral and written communication skills, including effective listening.

Responsibilities

• Lead day-to-day QC team performance for analytical testing of samples and products.
• Ensure analytical chemistry functions comply with safety, quality, and documentation standards.
• Supervise scientists; manage motivation, education, efficiency, performance and productivity.
• Ensure laboratory operations are conducted safely and follow the Chemical Hygiene Plan.
• Maintain compliance with regulations; adhere to SOPs and cGMPs.
• Organize workloads and coordinate multiple projects to meet objectives, timelines, and deadlines.
• Conduct investigations of OOS, deviations, change control management, and CAPAs.
• Support drug product manufacturing through pharmaceutical analysis.

Skills

Team leadership

Quality systems

Regulatory knowledge

Analytical testing

Education

Bachelor’s degree in Chemistry

Tools

HPLC

UPLC

GC

Microsoft Office

Job description

Hartmann Young is partnered with a global contract development and manufacturing organisation (CDMO) with over 30 years of experience partnering with pharmaceutical and biotechnology companies to support the development, manufacture, and delivery of therapies for patients. We are looking for a Quality Control Supervisor to join the team in Albany, New York.

Please note: This is a permanent day shift position. Candidates must be able to work day shifts on an ongoing basis.

The Role

The Quality Control Supervisor is responsible for leading the execution of both routine and non-routine analytical chemistry testing of raw materials, in-process samples, finished APIs, and special project samples. The role provides day-to-day oversight of Quality Control laboratory operations, ensuring activities are carried out efficiently and in compliance with relevant quality standards, while managing and developing a team of Quality Control Chemists.

Day to day, you will:

• Manage the Quality Control Team Performance of analytical testing for various samples and incoming, in process and final products;
• Ensure that the analytical chemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely;
• Supervise a team of scientists including the motivation, education, efficiency, performance management and productivity of each team member;
• Ensure that laboratory operations are conducted in a safe manner. Remain familiar with the contents of the Chemical Hygiene Plan. Follow safety rules fully;
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary;
• Organize workloads and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines;
• Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs;
• Supervise and perform pharmaceutical analysis to support drug product manufacturing.

The Person

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field;
• Minimum 5 years’ experience in a cGMP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation, including a minimum of 2 years supervisory experience;
• Demonstrated ability to effectively utilise team resources;
• Expert in cGMP, USP, EP and FDA regulations;
• Strong oral and written communication skills, including effective listening.

The ideal candidate will demonstrate initiative by identifying priorities, taking appropriate action, and delivering results. They will effectively leverage team resources to achieve objectives, while applying strong technical knowledge to understand the theory and interpret results from a range of laboratory techniques. They will also be proficient in Microsoft Office Suite, including Excel and Word, as well as other relevant computer software required for the role.

Relocation support is also available for this role.