The ability to fluently read, write, understand, and communicate in English.
Follow procedures with decision-making authority, requiring job-related training, attention to detail, and reliability in an aseptic pharmaceutical manufacturing environment.
Work within paper and computerized systems to maintain quality production and documentation.
Collaborate with QA Operations team and members of production to produce quality units.
Monitor product quality at different stages and detect, escalate, and work to resolve non-conformances in a timely manner.
Maintain accurate and complete documentation and ensure rigorous quality control.
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.
Must be team-oriented, quality-minded, physically able to stand and walk for long periods of time, and able to communicate clearly.
Preferred Qualifications/Skills/Experience
Strong data analysis and decision-making skills.
Excellent organizational and communication abilities.
Proficient in Microsoft Office (Excel, Outlook, etc.).
Aseptic, Packaging, and/or Compounding knowledge.
Quality mindset.
Experience in SAP and/or LabVantage.
Risk-based decision-making skills working with cross-functional teams