10-PuertoRico-PRI01-Operator I (Rotational Shift)

Baxter International Inc.•Guayama, PR

2d•Onsite

About The Position

At Baxter, every person deserves a chance to live a healthy life, a founding belief since 1931. The company is redefining healthcare delivery to make a greater impact, united by a Mission to Save and Sustain Lives. Colleagues are driven by a culture of courage, trust, and collaboration, empowered to take ownership and make a meaningful impact, striving for efficient and effective operations and accountability for exceptional results. The Fill & Pack Operator I's main responsibility is to execute required manufacturing activities and operate manufacturing equipment following applicable Standard Operating Procedures.

Requirements

Ability to read and understand English & Spanish
Basic cGMP knowledge
Comprehensive knowledge of cGMP, FDA & EHSS regulations
Must possess good record keeping skills
Must be able to work rotating shifts, weekends and holidays
Computer literate (Word, Excel, Power Point)
Ability to operate electronic equipment
Capable of operating automatic and semi-automatic equipment
Ability to add, subtract, multiply, divide and calculate percentages as well as able to use a calculator or other associated electronic equipment.
Ability to follow written procedures and/ or verbal instructions communications by telephone, fax or shortwave radios.
Vocational or High School Diploma
No experience required

Responsibilities

Perform manufacturing operations and operate equipment/machine by following standard operating procedures adhering to Good Manufacturing Practices (GMP's) and Good Documentation Practices (GDP's).
Be capable of operating multidisciplinary activities including 80% of the stations at the packaging lines and 50% of the clerical tasks.
Perform set-up, clean up and operation of manufacturing equipment such as filling, labeling and packaging processes among others.
Follow all safety rules regarding equipment/machine operation and proper guarding as well as maintaining a safe and clean work environment by following organizational standards.
Guarantee adequate equipment execution to assure that it is performing as required, minimizing the opportunities of process defects or non-conformity events.
Perform product/process inspections in selected areas to assure product conformity to established requirements.
Assure that the filling station is operated efficiently and each lot delivers the expected yield.
Acknowledge and maintain commitment with the environmental policy, and participate actively in the environmental programs to achieve established objectives and goals.
Comply with environmental regulations related to handling of hazardous materials applicable to the area.
Assist in trainings to new production operators on manufacturing area procedures by providing on-the job training (OJT) and provide support for equipment and process validations.
Assure that materials are properly verified and available to maintain a continuous process flow while assisting lead operator on revision of packaging modules to guarantee correctness and completeness of documents.
Be responsible for completing documents (filing, labeling, packaging modules, protocols, reworks, etc.) related with manufacturing in an exact and correct form per regulatory requirements.
Acknowledge established metrics and process goals of the area as required; may initiate root cause analysis and corrective actions as necessary by assisting in the control of processes for materials with minimum scrap and rework.