Overview Under general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications; performs incoming sampling and inspection of products.
Responsibilities Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
• Monitors, conducts, coordinates and documents results of sampling and inspection of incoming materials, sampling and inspection of the packaging process, and sampling and testing of products in compliance with procedures and guidelines for commercial validation, stability in retrieval activities and operational requirements.
• Monitors execution of the sampling and inspection procedures in accordance with product item code and current BMR/PO specifications.
• Performs or assists in coordinating label room activities including approval, issuance, handling and control of all printed components, materials and related documentation complies with DPPEI procedures and federal regulations.
• Provides sampling and incoming inspection to determine acceptability of raw materials and packaging components; determines compressed, coated and encapsulated products meet the established specifications for physical tests and appearance.
• Maintains working areas, safe, clean, organized and well identified in compliance with all SOP/IOP, cGMP, and safety rules and regulations.
• Notifies supervisor of any deviation, incident and/or non-conforming situations, and assists in the investigation of situations and the internal audit program.
• Maintains accountability of all returned roll labels, inserts from labeling operation, accountability logbooks and inventory balance records.
• Responsible for the control expediting and segregation of printed materials and filing of documentation related to the receipt, dispatch and returned materials.
• Assists in the training of new employees and updating of training due to revision of policies and procedures.
• Receives, has custody, retains and stores retention samples of filled labeled bottles and inserts for each production lot; or materials in assigned area.
• Performs all duties in a timely manner; adheres to all cGMP regulations, Corporate, Company and site good housekeeping, safety and operating policies and procedures.
• Performs related duties as assigned.
Qualifications Knowledge of:
• Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
• Sampling techniques and methods for assigned area
• Labeling processes and techniques.
• Computer applications and programs related to the area of assignment
• Principles of mathematical and statistical computations. Skill in:
• Establishing and maintaining cooperative working relationships with others.
• Reading, reviewing, sampling, counting and maintaining inventories and logs for materials in assigned area.
• Reading, understanding, interpreting and complying with current Company policies and procedures including safety rules and regulations.
• Communicating clearly and concisely, both orally and in writing.
• Operating personal computer and database software.
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, bending, stooping crouching, crawling, and climbing, vision to monitor, moderate noise levels, and lifting, pushing, pulling parts and equipment weighing up to 30 pounds. Work is performed in office and laboratory environments with exposure to electrical hazards, danger tools and equipment, antibiotics penicillin and/or cephalosporin.
Minimum Qualifications: High School Diploma or equivalent and two (2) years manufacturing and/or warehouse environment experience or one (1) year of satisfactory performance as Inspector I.
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With 58,000 employees in over 60 countries worldwide, we are proud to say that our employees are the reason for our sustained success. Their skills and dedication make us an industry leader. The diversity of perceptions, qualifications and talent are the key to our ongoing accomplishments. We offer a wide range of jobs and genuine opportunities for personal and professional advancement.