DEVIATIONS / INVESTIGATIONS SPECIALIST
WEST POINT, PA

Top skillset needed - Investigation Writing experience.
DM experience, Customer Compliant Experience and Root Cause Analysis experience preferred.

Required Skills:

• B.S./M.S. degree in appropriate engineering/scientific field.
• 0-3 years post-Bachelor's degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) in Pharmaceutical/ Biotech industry.
• Previous experience in writing investigations for atypical events in a manufacturing environment.
• Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Demonstrated ability to work both independently and as a part of a cross-functional team.
• Excellent written and verbal communication skills.

Project Description:

• Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations.
• Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery.
• Performing deviation investigations and customer complaints aimed to prevent deviation/complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.
• Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times.
• Supporting team safety, environmental and compliance objectives.
• Managing investigation and complaint timelines to ensure key compliance and customer due dates are met, escalating any potential misses, and developing remediation plans when possible.
• Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning).
• Actively using and championing the use of Lean Six Sigma (LSS) and the Client's Production System (MPS) tools, both in problem solving and day-to-day operational activities.

This 5+ month position starts ASAP.

ALPHA'S REQUIREMENT # 23-00812
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Types: Full-time, Contract

Pay: $41.19 - $42.40 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Vision insurance

Schedule:

• Monday to Friday
• Weekend availability

Work Location: In person

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