Supervisor, QC Stability

Hartmann Young; City of Albany (NY); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Hartmann Young in Albany, NY is seeking a Supervisor, QC Stability to lead the stability testing team and oversee analytical chemistry assays for stability samples, with occasional testing of materials and finished products.

The role emphasizes regulatory compliance, cGMP adherence, and safe laboratory operations. You will organize workloads, drive investigations of OOS/Deviations, and ensure timely documentation while mentoring a skilled team.

Qualifications

• Bachelor’s degree in Chemistry or Analytical Chemistry or related field.
• Minimum 5 years’ GMP/FLP experience with chromatography.
• Minimum 2 years supervisory experience in GMP/quality environment.
• Strong oral and written communication skills.
• Expert in cGMP, USP, EP and FDA regulations.

Responsibilities

• Oversee Quality Control Stability testing and manage the stability testing team.
• Ensure analytical chemistry functions comply with safety and quality standards and document all experiments.
• Maintain safe laboratory operations and uphold the Chemical Hygiene Plan.
• Coordinate workloads and multiple projects to meet objectives and deadlines.
• Investigate OOS, deviations, change controls, and CAPAs.
• Support drug product manufacturing through pharmaceutical analysis.

Skills

Team leadership

Analytical chemistry

Regulatory knowledge

Education

Bachelor’s degree in Chemistry/Analytical Chemistry

Tools

HPLC/UPLC/GC

Job description

Supervisor, QC Stability - relocation support available

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 Supervisor, QC Stability to join the team in Albany, New York.

The role

The Quality Control Stability Supervisor is primarily responsible for overseeing routine analytical chemistry assays of stability samples, with occasional testing of raw materials, in-process samples, finished APIs, and/or special projects. This role will oversee the day-to-day functions of their department and manage a team of Quality Control Chemists focused on stability testing.

You’ll also:

• Manage of Quality Control Stability Team Performance of analytical testing for various stability 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;
• Ensure that laboratory operations are conducted in a safe manner;
• Remain familiar with the contents of the Chemical Hygiene Plan;
• Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary;
• Organise 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 GMP or FLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation, including a minimum of 2 years supervisory experience;
• Strong oral and written communication skills, including effective listening;
• Demonstrated ability to effectively utilise team resources;
• Expert in cGMP, USP, EP and FDA regulations.

Please note - relocation support is available for this position.