Position Summary:

• Performs any one or combination of production line and material handling in manufacturing.
• Responsible for achieving production standards in manual operations and/or while operating equipment requiring average mechanical skills and aptitude.
• Responsible for achieving standard production rates, following safety, compliance, and company policies and practices.
• Responsible for accurate and timely documentation of work in batch records, log books and other official documents.

Essential Duties & Responsibilities:

• Inspect components, materials, documents and final products either as inherent part of the production process or off line.
• 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.
• Identify non-conforming product (rejects).
• 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. Adapt to changes in a constructive manner.
• 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, SOP’s, and plant policies/rules.
• All other duties as deemed necessary by supervisor or manager.
• 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.

Knowledge & Skills:

• Ability to read, write, understand, and communicate in English.
• Must accurately follow both verbal and written instructions.
• 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.

Minimum Qualifications, Education & Experience:

• High School education or equivalent required.
• Must be at least 18 years of age Work Environment.
• Typically requires travel less than 5% of the time.
• This position is required to ensure production standards are met.
• Varying levels of physical activity based on specific assignment.
• Must wear hearing protection, safety shoes, prescription glasses (if prescribed), and any/all personal protective equipment (PPE) required to perform jobs in assigned areas.
• May be required to work outside and its elements, to assist with material disposition.
• Must be able to lift up to 35 lbs. unassisted and up to 75 lbs. assisted.