Assembler 3, General

Assembler III, General

Under direct supervision, trains to perform duties related to the preparation and manufacture of active pharmaceutical ingredients, intermediates, and/or medical devices in accordance with standard operating procedures, as regulated by quality, environmental, and safety agencies (FDA, OSHA, etc.).

Responsibilities include:

• Responsible of completing required documentation (such as batch records, returns, etc.)
• Responsible of leading/guiding machine operators
• Possess a basic understanding of production processes within area of assignment and a working knowledge of manufacturing equipment
• Follow GMP's and standard operating procedures
• Follow process and utility flow diagrams
• Transport materials of varying weight in accordance with established safety guidelines using material handling equipment and additional assistance as required
• Perform area safety inspections to identify safety hazards and report findings in accordance with company protocols
• Demonstrates adherence to safety procedures by monitoring personal and peer behaviors, work environment and housekeeping
• Participate in internal audits and support additional team activities as requested
• Participate on site investigative teams and where applicable, NCR, s and behavioral safety assessments. Correct and/or mitigate findings from assessments
• Provides overtime as needed
• Performs all duties with attention to quality, safety and environmental matters
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, and OSHA
• Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise
• Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties
• Complete all regulatory training as assigned (GPM's, ISO14001, OSHA, etc.)
• Complete Operator Training Program according to established guidelines
• Be available for other projects or assignments as requested by management
• Continuously looks for ways to simplify or improve products, services, systems, and processes to achieve business goals
• Makes a positive contribution through demonstration of ability to seek out assistance from co-workers as needed; to suggest ways to improve upon current operations practices and systems; and to learn new skills, procedures and processes

Qualifications:

• High School Diploma or (GED), Preferred
• 12 months of work experience in a manufacturing environment is required
• Work experience in chemical, pharmaceutical, or industry that complies with GMP is highly preferred
• Must be able to read, write, and understand Basic English
• Operating skills of manufacturing equipment, tools, and hand/fork lifts is preferred
• Basic PC navigation such as the ability to enter data into programs/software applications as instructed and use software applications for mail, word processing, spreadsheets and other job specific needs is preferred
• Ability to communicate and effectively work as part of a team is required