Senior Supervisor, Quality Control - NY

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:

SENIOR SUPERVISOR, QUALITY CONTROL in Rensselaer, NY

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Senior Quality Control Supervisor is responsible for overseeing routine and non-routine analytical chemistry assays of raw materials, in-process samples, cleaning 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. This position may require work outside of normal business hours as needed.

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.

Supervisory responsibilities

• This position does have supervisory responsibilities.
  
  Essential job duties
  
• Manage the Quality Control Team Performance of analytical testing for various samples and incoming, in process, cleanings 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
  
• Supervise and lead in process control supervisor
  
• 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 and supplier qualifications
  
  Education, experience, certification and licensures
  
• Ph.D. Degree in Analytical Chemistry or related field
  
• Minimum 5-8 years' relevant experience, including 3 years' minimum supervisory experience
  
  OR
  
• Master's degree in Analytical Chemistry or related field
  
• Minimum 8-12 years' relevant experience, including 3 years' minimum supervisory experience
  OR
  
  • Bachelor's degree in Analytical Chemistry or related field
    
  • Minimum 12-14 years' relevant experience, including 3 years' minimum supervisory experience
    
  • Minimum 5 years' experience in a GMP or FLP environment working with Chromatography (HPLC/UPLC/GC)
    
  • 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
    
    All interested applicants must apply online. 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.
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Keywords: Curia, New Haven , Senior Supervisor, Quality Control - NY, Other , Amityville, Connecticut