Visual Inspection Operational Lead

Job Title: Visual Inspection Operational Lead

Location: Raleigh, NC

Job Type: Contract to Hire

Organization Overview:

The Visual Inspection Operational Associate (OA) plays a critical role in the successful startup and ramp-up of new Parenteral Operations at a site. Working closely with the Visual Inspection Process Team (PT), this position supports the implementation of the Operational Readiness roadmap and ensures the appropriate business processes are in place to support team effectiveness. The OA will oversee and implement operational readiness, driving the transition from Project phase to routine production, while collaborating with the Site, RAMP/Acceleration Team, GPP, and all other necessary functions.

Key Responsibilities:
Leadership & Process Improvement: Serve as a role model for the Visual Inspection PT by driving best practices and behaviors aligned with the Manufacturing Standard Operating Environment (MSOE). Encourage the team to adopt efficient, safe, and quality-driven practices.
Batch Issue Resolution: Identify batch-related challenges, particularly those arising from poorly designed or missing processes, and take proactive steps to resolve these issues. Ensure that corrective actions are identified and implemented for smoother operations.
Standard Work Creation & Documentation: Develop and maintain standard work documents, process maps, and tools that ensure right-first-time execution and long-term sustainability in visual inspection operations.
Operational Readiness Support: Support the implementation of the Operational Readiness roadmap for the Visual Inspection Process Team, overseeing all aspects of readiness for the transition from project phase to routine production.
Cross-Functional Collaboration: Work closely with the Site, RAMP/Acceleration Team, GPP, and other functions to ensure successful operational readiness. Act as the key liaison for ensuring alignment across teams and the smooth execution of the ramp-up process.
Process Optimization: Continuously evaluate the visual inspection processes, workflows, and systems for improvement opportunities. Identify and implement solutions to maximize efficiency, reduce waste, and improve Overall Equipment Effectiveness (OEE) during the transition to routine production.
Mentorship & Capability Building: Mentor and develop team members by providing guidance on best practices and operational techniques to support their professional growth and strengthen the overall capabilities of the Visual Inspection PT.
Support Continuous Improvement: Drive a continuous improvement mindset within the team by identifying opportunities to enhance the visual inspection process, supporting data-driven decisions, and contributing to cross-functional improvement initiatives.
Inspection Readiness & Compliance: Ensure the Visual Inspection process is compliant with all regulatory requirements, including GMP (Good Manufacturing Practices), safety, and quality standards. Support the team in preparing for internal and external audits.

Qualifications:
Education: Bachelor's degree in Life Sciences, Engineering, or a related field. Additional certifications in Quality Control, Visual Inspection, or Manufacturing Operations are a plus.
Experience: 2-4 years of experience in pharmaceutical or biotechnology manufacturing, with a focus on visual inspection or quality control. Experience with Parenteral operations or aseptic manufacturing is highly desirable.
Skills:
Strong understanding of GMP and visual inspection processes, as well as regulatory compliance requirements.
Ability to identify and resolve operational challenges, particularly in batch-related processes.
Proven experience in creating standard work documents, process maps, and operational tools.
Excellent communication and collaboration skills, with the ability to work cross-functionally across various teams.
Strong problem-solving skills and a proactive, solutions-oriented approach to work.
Knowledge of continuous improvement methodologies (e.g., Lean, Six Sigma) is a plus.
Ability to mentor and build the capability of the team, ensuring they are well-prepared for routine operations.

Job Type: Temp-to-hire

Pay: $70.00 - $80.00 per hour

Expected hours: 40 per week

Schedule:
8 hour shift
Monday to Friday

Application Question(s):
Are you currently located in Raleigh, NC?

Ability to Commute:
Raleigh, NC 27668 (Required)

Ability to Relocate:
Raleigh, NC 27668: Relocate before starting work (Required)

Work Location: In person