Associate Director, Quality Control - NY

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

Job Description:

The Associate Director of Quality Control also ensures compliance of the analytical laboratories and operations to the most current data integrity requirements, drives continuous improvement activities and implementation of industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level. The Associate Director will interact with Curia internal and external customers.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does have supervisory responsibilities.

Essential job duties

• Direct the Quality Control department. This includes, but is not limited to, scheduling and overseeing testing and operations of quality control team(s) responsible for samples and incoming, in-process and final products testing, coaching and mentoring QC analysts, supporting troubleshooting activities and investigations
  
• Ensure QC laboratories, and operations are cGMP compliant. This include but is not limited to overseeing of analytical equipment qualification, maintenance and calibration programs, ensuring that QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements and that QC investigations and thoroughly conducted
  
• Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
  
• Define the need of the laboratory in terms of equipment and people. Responsible for preparing QC budget of expenses and Capex
  
• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide while maximizing efficiency of the QC laboratory to achieve the site business goals
  
• Collect, monitor and report quality control key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality, productivity and efficiency of the QC department
  
• Support Curia global quality and continuous improvements initiatives. Recommend and implement methods and techniques to increase the quality of products and/or service
  
• Oversee pharmaceutical analysis to support drug product manufacturing
  
• Mentor, coaches and provide in continuing training to QC personnel to increase the level of technical skills and compliance in the department
  
  Education, experience, certification and licensures Required Bachelor's/Master's degree in Chemistry, Analytical Chemistry or related field Minimum 12-15 years' experience in the pharmaceutical industry in drug substance or drug product manufacturing, including 5 years' experience in Quality Control Minimum 10 -15 years' experience in a professional management role Preferred Advanced degree in Chemistry, Analytical Chemistry or related field Knowledge, skills and abilities
  
• Combined ability to mentor and coach individuals and ability to motivate teams to reach a common goal
  
• Strong knowledge of cGMP regulations applicable to API manufacturers, including FDA regulations
  
• Strong knowledge of analytical techniques, such as HPLC, GC, PSD, and wet chemistry with proven ability to solve complex problems
  
• Strategic thinking
  
• Strong communication skills
  
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  
• Ability to write reports, business correspondence, and procedure manuals
  
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
  
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
  
• Ability to apply concepts of basic algebra and geometry
  
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  
  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 , Associate Director, Quality Control - NY, Executive , Amityville, Connecticut