Quality Assurance Compliance Specialist - NY

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

Job Description:

Quality Assurance Compliance Specialist in Rensselaer, NY

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

The Quality Assurance Compliance Specialist supports Quality metrics while ensuring compliance with all Regulatory Agency requirements.

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.

In this role, you will:

• Assist the Quality Assurance Manager in ensuring compliance with all Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the Rensselaer site
  
• Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
  
• Support all the Regulatory Agency inspections at the site and the preparation of CAPAs, and monitor the completion of assigned tasks.
  
• Lead and drive the GMP activities, work with manufacturing Managers and supervisors to complete the deviation investigations on time
  
• Responsible driving the established Quality Metrics
  
• Review and approve master batch records as and when required.
  
• Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
  
• Report serious or repeated observations or serious compliance gaps to quality management.
  
• Manage the Internal Audit program including coordination of auditors within the QA department.
  
• Interact with the Curia Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within Curia.
  Qualifications:
  • Minimum Bachelor of Science degree in Chemistry or a related field
    
  • Minimum 5-10 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities
    
  • Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
    
  • Knowledge of pharmaceutical processes.
    
  • USFDA inspection experiences (participating or leading)
    
  • Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
    
  • Proficient in building consensus, negotiating and escalating issues
    
  • Good understanding of the importance and use of quality metrics
    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, Decatur , Quality Assurance Compliance Specialist - NY, Other , Decatur, Illinois