Description:
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
In this position the Essential Functions:
Responsible for completing required documentation (such as batch records, returns, etc.).
Possess a basic understanding of production processes within area of assignment and a working knowledge of manufacturing equipment.
Operate equipment in accordance to applicable manufacturing instructions/ operating procedures including machine set-ups and parameter documentation.
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, Client, s and behavioral safety assessments. Correct and/or mitigate findings from assessments.
Available for overtime as needed
Performs all duties with attention to quality, safety, and environmental matters such as wearing appropriate personal protective equipment, identifying, reporting, and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, and properly labeling and storing chemicals.
Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, and OSHA. Complies with all company and site policies and procedures.
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.
Looking for ways to simplify or improve products, services, systems, and processes to achieve business goals, e.g., improve yield, cycle time, quality, and productivity.
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/GED or 4 months of work experience in a manufacturing environment preferred.
Work experience in chemical, pharmaceutical, or industry that complies with GMP is highly preferred.
Able to read, write, fluently English preferred.
Operating skills of manufacturing equipment, tools, and hand/pallet jack is preferred.
Basic Computer Skills preferred
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 preferred.
Ability to communicate and effectively work as part of a team is required.