Specialist QA

We are seeking a Sr. Specialist QA with experience in regulated industries:

Responsibilities:

• Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
  
• Actively engage in continuous improvement initiatives, programs, and projects.
  
• Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
  
• Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
  
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  
• Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
  
• Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
  
• Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
  
• Accountable for adherence to assigned training, permitting execution of required tasks.
  
• Champion continuous improvement initiatives and projects.
  
• Provide support and oversight for New Product Introduction (NPI).
  
• Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
  
• Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
  
• Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
  
• Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
  
• Validated experience serving as Quality Contact for complex projects involving new products.
  
• Validated experience in commissioning and qualification.
  
• Strong organizational skills, including the ability to follow assignments through to completion.
  
• Enhanced skills in leading, influencing, and negotiating.
  
• Demonstrate the ability to interact effectively with regulatory agencies.
  
• Solid word processing, presentation, database, and spreadsheet application skills.
  
• Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
  
• Proven skill in working independently and effectively interacting with all levels throughout the organization.
  
• Advanced data trending and evaluation abilities.
  
• Ability to evaluate compliance issues.
  

Requirements

• Education: Bachelors Degree in Science or Engineering  + 4 years of directly related experience.
  
• Bilingual (English & Spanish)