Quality Assurance Associate - Multiple Shifts

The Quality Assurance (QA) Associate works closely with the QA Manager to ensure compliance with regulatory standards, industry requirements, and internal SOPs. This role is instrumental in cultivating a strong quality culture across the organization, emphasizing efficiency, precision, and timely deliverables. The QA Associate will identify and address operational and quality issues while maintaining a proactive approach to quality management.

Key Responsibilities

• Act as a QA representative on the production floor to ensure processes meet quality standards.
• Review and approve records such as batch documentation, logbooks, work orders, and procedures.
• Partner with manufacturing teams to lead or assist in resolving equipment and process deviations.
• Aid in batch record reviews, material release, and other quality-related functions.
• Balance production schedules with quality assurance requirements to meet deadlines without compromising quality.
• Evaluate deviations, recommend corrective actions, and escalate critical issues to management when necessary.
• Contribute to investigations using root cause analysis, report findings, and develop mitigation strategies with risk assessment tools.
• Advocate for safety and compliance, encouraging adherence to established SOPs, quality guidelines, and organizational goals.
• Utilize electronic and manual systems (e.g., quality management software, monitoring systems, laboratory tools) to maintain data accuracy and compliance.
• Analyze deviations and identify opportunities to enhance operational consistency and reduce variability.
• Manage multiple projects effectively in a fast-paced work environment.

Requirements

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Microbiology) or equivalent work experience required.
• Experience:
  • At least 2 years in a GMP-compliant manufacturing environment, either in QA or production roles.
  • Familiarity with quality systems, including deviation management, non-conformance handling, and CAPA processes.
  • Strong understanding of Good Documentation Practices (GDP).
• Skills:
  • Excellent communication skills, both written and verbal.
  • Proficiency with operational tools and data analysis software (e.g., Word, Excel, statistical tools).
  • Effective interpersonal skills with the ability to work collaboratively and influence positive outcomes.
  • Highly organized with strong self-management abilities.

Preferred Qualifications

• Hands-on experience with sterile or aseptic manufacturing environments.
• Knowledge of Continuous Improvement methodologies, such as Lean principles or Six Sigma.