Senior QA Investigation Specialist - NY

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

Job Description:

Senior Quality Assurance Investigation Specialist- Onsite position in Rensselaer, NY

Position Overview

The Senior Quality Investigation Specialist plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The role is responsible for overseeing and providing support for GMP investigations, internal audits, and customer complaint investigations. This role serves the Quality Assurance Department by implementing all procedures leading to compliant, valid, and documented release of drug substances by performing the following duties personally or through subordinate specialists. The Senior Quality Investigation Specialist participates in, writes and/or closes investigations. This requires maintaining budgetary targets and delivering earnings and growth to the company.

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 may directly supervise up to four employees in QA, which requires the position to carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Essential job duties

• Provide QA oversight and subject matter expertise for GMP investigations
  
• Review GMP documents for company and contractor/customers
  
• Support and conduct product complaints, deviations, and failure investigations
  
• Contribute to Curia's core values of Quality, Timeliness, Communication and Profitability
  
• Conduct investigations or closure of major investigations and customer complaints
  
• Perform root cause analysis and implementation of corrective action for process related concerns
  
• Recommend and enact changes to applicable SOPs
  
• Support Curia Compliance department during FDA and other agency inspections as well as customer and internal audits
  
• Maintain a working knowledge of government and industry quality assurance codes and standards
  
• Participate in site or global projects and improvement efforts, as needed
  
• Establish and maintain effective working relationships with Supply Chain Management, Production and Warehouse/Distribution staff, corporate and site Quality, project management and regulatory affairs
  Requirements:
  
  Education, experience, certification and licensures
  • Bachelor's Degree in Science, Chemistry, or Biology
    
  • Minimum 12-15 years' experience in quality assurance and/or regulatory experience in the Pharmaceutical industry
    
    OR
    
  • Minimum 18 years' experience in Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing
    
    Knowledge, skills and abilities
    
  • Must have knowledge of the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical laboratory
    
  • Excellent verbal and written communication skills, including the ability to present information to large or small groups, and interact with customers
    
  • Proficient in time and project management. Ability to develop plans and delegate responsibilities
    
  • Ability to work independently and as a team leader
    
  • Able to organize and write clear, concise and complex technical documents, reports, and assessments
    
  • Extensive knowledge of cGMP, EU and other country regulations involved in the technical development and manufacturing processes of pharmaceutical drug products
    
  • Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA and FDA
    
  • Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations, Chapter 21, Part 11
    
  • Familiar with instrument manufacture-based systems (Totalchrom, Empower), laboratory software, and Microsoft Office
    
  • Must also have extensive working knowledge of Trackwise, Document Management Systems (e.g., Master Control or Trackwise) and Batch Record Tracking
    
  • Ability to adapt to frequent changes, delays or unexpected events in a fast-paced work environment and change procedures to best fit the situation
    
  • Ability to research, collect, and analyze complex data and information, synthesize complex problem solutions, and design work flows and procedures based on results
    
  • Excellent customer service skills
    
  • Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions
    
  • 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 work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
    
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
    
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
    
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
    
    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 talk or hear. The employee is frequently required to sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
    
    Work Environment
    
    The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually quiet.
    
    The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.
    
    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.
    
    #LI-KS1
    

Keywords: Curia, Decatur , Senior QA Investigation Specialist - NY, Other , Decatur, Illinois