Supervisor, Quality Control Stability

Curia; City of Rensselaer (NY); On-site; USD 87,000 - 108,576; Full time

Benefits offered by this job

Generous benefits

Paid training

Career advancement

Education reimbursement

401k program

Learning platform

Job summary

Curia is seeking a Stability Supervisor in Quality Control to guide stability testing of samples, raw materials, in-process and final products. Lead a QC Chemists team, ensuring compliance with regulatory and safety standards while coordinating multiple projects and timelines.

Responsibilities include supervising method development/validation, ensuring accurate documentation, and investigating OOS/Deviations.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field
• Minimum 5 years’ GMP/FLP experience with chromatography, method development/validation
• Supervisory experience of a team of scientists
• Strong communication skills (oral and written)
• Expert knowledge of cGMP, USP, EP, and FDA regulations

Responsibilities

• Oversee QC Stability Team performance for stability samples and finished products
• Ensure analytical chemistry work adheres to safety and quality standards
• Supervise scientists including coaching, performance management and productivity
• Maintain safe laboratory operations per Chemical Hygiene Plan
• Ensure compliance with regulations and SOPs; manage multiple projects
• Conduct investigations of OOS, deviations, change control and CAPAs
• Support drug product manufacturing through pharmaceutical analysis

Skills

HPLC/UPLC

GC

Team supervision

GMP familiarity

Regulatory knowledge

Education

B.S. or higher in Chemistry

Tools

Chromatography instruments

Job description

Stability Supervisor, Quality Control

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. This position may require work outside of normal business hours as needed.

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

We Proudly Offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401k program
• Learning platform
• And more!

Supervisory Responsibilities

This position does have supervisory responsibilities.

Essential Job Duties

• Manage the 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
• Supervise a team of scientists including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
• 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

Education, Experience, Certification And Licensures Required

• 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 utilize team resources
• Expert in cGMP, USP, EP and FDA regulations

Knowledge, Skills And Abilities

• Ability to recognize what needs to be done, take action, and accomplish results
• Strong oral and written communication skills, including effective listening
• Demonstrated ability to effectively utilize team resources
• Expert in cGMP, USP, EP and FDA regulations
• Technical competence including the understanding of theory and interpretation of all lab techniques
• Proficient use of computer software, including Microsoft Office Suite (excel, word) and other required software
• Strong organizational skills with the ability to multi-task
• Proficient in HPLC and GC method development and method validation with extensive experience with multiple other analytical techniques and analytical equipment
• Prior experience and knowledge in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485, and ICH Stability guidelines.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; and sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

Pay range: $87,000 - $108,576

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.