Quality Assurance Supervisor - 3rd Shift

The Quality Assurance (QA) Supervisor will lead QA initiatives to ensure compliance with regulatory standards, industry requirements, and internal SOPs. This position is integral to fostering a culture of quality across the organization, focusing on efficiency, precision, and timely deliverables. The QA Supervisor will oversee QA personnel, manage quality processes, and collaborate with cross-functional teams to resolve operational and quality-related challenges.

Key Responsibilities 

• Supervise and mentor QA staff, ensuring alignment with company goals and adherence to quality standards.
• Act as the primary QA representative on the production floor to monitor and enforce compliance with established processes.
• Review and approve critical records such as batch documentation, logbooks, work orders, and procedures.
• Deviation and Investigation Management:
  • Lead efforts to identify, evaluate, and resolve equipment and process deviations.
  • Oversee investigations using root cause analysis and risk assessment tools.
  • Develop and implement corrective and preventive actions (CAPAs).
• Partner with manufacturing and operational teams to support quality initiatives and improve process efficiency.
• Oversee QA review of batch records and facilitate material release processes.
• Champion a culture of safety and compliance, ensuring adherence to SOPs, quality guidelines, and regulatory requirements.
• Manage and maintain data accuracy within electronic and manual quality systems, ensuring process integrity and compliance.
• Analyze deviations and operational trends to identify and implement opportunities for quality and process improvements.
• Coordinate and prioritize multiple projects in a fast-paced, dynamic work environment.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Microbiology) or equivalent work experience required.
• Experience:
  • Minimum of 3–5 years in a GMP-compliant manufacturing environment, with at least 1–2 years in a leadership or supervisory role.
  • Demonstrated expertise in quality systems, including deviation management, non-conformance handling, CAPA, and document control processes.
  • Strong understanding of Good Documentation Practices (GDP).
• Skills:
  • Excellent written and verbal communication skills.
  • Proficiency with quality management systems and data analysis tools (e.g., Microsoft Word, Excel, and statistical software).
  • Strong organizational and multitasking abilities.
  • Effective interpersonal skills with the ability to mentor team members and influence cross-functional outcomes.

Preferred Qualifications

• Hands-on experience in sterile or aseptic manufacturing environments.
• Certification in Continuous Improvement methodologies, such as Lean principles or Six Sigma.
• Familiarity with implementing and maintaining electronic Quality Management Systems (eQMS).

The QA Supervisor role offers an exciting opportunity to lead quality assurance efforts within a biopharmaceutical company dedicated to delivering high-quality products. This position is ideal for a proactive leader with a passion for quality and a commitment to excellence in a regulated environment.