Quality Program Manager - ABQ

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

Job Description:

The Quality Program Managers will take the lead with ensuring compliance with cGMPs, company, customer and regulatory quality standards according to requirements. Specifically, the Quality Program Manager will be responsible for directly interfacing with the Curia-Albuquerque customers with respect to all matters related to Quality. Additionally, the Quality Program Manager will work directly with the Site Head of Quality with customer related issues.

Essential Duties and Responsibilities:

• Acts as the primary quality assurance contact for clients, Curia-Albuquerque service department, and technical project management department.
  
• Responsible to ensure batch records have been thoroughly reviewed prior to release.
  
• Responsible for release of product lots to the customer.
  
• Responsible for closure of customer complaint investigations.
  
• Recommends changes to all applicable SOP's.
  
• Analyzes data for trends, develops continuous improvement plans and acts on trends.
  
• Effectively coordinates functions of internal QA organization with client and necessary Curia-Albuquerque departments.
  
• Effectively communicates within company and internal departments, outside vendors and professional organizations.
  
• Interfaces with the other Curia-Albuquerque Departments and customer service department as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure highest quality standards and regulatory compliance.
  
• Responsible for establishing and maintaining systems and procedures to ensure compliance of Curia-Albuquerque with all applicable regulations.
  
• Coordinates key systems including change control, inventory control, batch records (Manufacturing and Packaging) and other functions impacting the quality area and related to assigned products and clients.
  
• Supports Curia-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits.
  
• Works with customers having products formulation or tested in defining quality systems specific to product or services being rendered.
  
• Makes formal presentations within the company, to customers at site wide meetings and on-site wide projects.
  
• Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs.
  
• Provides all additional quality assurance support and functions as specified by the site head of quality.
  
• Ability to work in a timely manner and under pressure to meet customer and business deadlines associated with batch record lot release.
  Supervisory Responsibilities:
  Quality Assurance Product Specialist (QAPS) reports to Quality Product Manager
  Education and/or Experience
  
  • BS preferably in Science or a related field or equivalent experience.
    
  • At least 10 years industrial GMP experience in an FDA-regulated pharmaceutical environment.
    
  • Proficient in Microsoft Excel, Word, PowerPoint
    
  • Basic quality tools (i.e. pareto charts, histograms, cause-and-effect, root cause analysis)
    Language/Communication Skills
    
    Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations. Strong written and verbal communication and presentation skills including the ability to independently write develop and write procedures.
    
    Mathematical Skills
    
    Ability to calculate formulas and amounts such as: concentration, percentage, area, volume, and proportion. Ability to apply the mathematical concepts from algebra and geometry.
    
    Reasoning Ability
    
    Ability to solve problems with a variety of variables using past experience. Ability to interpret instructions furnished in written, oral, diagram, or schedule form.
    
    Physical Demands
    
    While performing the duties of this job, the employee is regularly required to sit; use hands to manipulate, handle, and feel; and able talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand; walk; and occasionally required to climb or balance; stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 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 is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet.
    
    Note
    
    This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
    
    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.

Keywords: Curia, New Haven , Quality Program Manager - ABQ, Executive , Amityville, Connecticut