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.