Job Description

Essential Duties & Responsibilities:

• Inspect components, materials, documents, and final products either as inherent part of the production process or offline.
• Performs activities specified in batch record and SOP's.
• Sample and evaluate product per defined methods, recognizes action levels and notifies area specialist and supervisor if out of limits.
• Perform and document lot changes, line clearances, production processes and cleaning operations. .
• Achieve established labor standards for the respective tasks.
• Provide information and feedback on commodity and process issues.
• Ensures quality products are delivered to subsequent processes.
• Work in a team environment to coordinate activities, solve problems, and effectively communicate.
• Participation in area improvements, cost reductions, and meetings. Provide information and feedback on commodity and process issues.
• Ensures quality products are delivered to subsequent processes.
• Adhere to cGMP guidelines, SOPs, and plant policies/rules.
• Able to evaluate process, product and equipment performance based on prescribed procedures.
• Work with team members to reach consensus to optimize quality, cost, compliance, customer service and safety.
• Perform other related duties as assigned or required, to include working in the outside elements for material disposition.
• Ability to perform and document basic mathematical calculations, (e.g. add, subtract, multiply, divide, work with fractions, decimals and percentages).
• Ability to perform minor mechanical adjustments, clear jams, evaluate product within specified limits and troubleshoot equipment.
• Must be able to pass the GMP test and obtain area certifications.
• High School education or equivalent required.
• This position is required to ensure production standards are met.
• Must wear hearing protection, safety shoes, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned areas.

Skills: Clean Room, Machine Operation, Assembly, Inspection, Manufacturing Tech, Production Operations

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