10-PuertoRico-PRI01-Operator I (Rotational Shift)-1

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Here, you will find more than just a job—you will find purpose and pride.

Summary of Position:

The Fill & Pack Operator I main responsibility is to execute the required manufacturing activities and operation of manufacturing equipment following applicable Standard Operating Procedures.

Essential Duties and 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).

• Operator I Must be capable of operate multidisciplinary activities including 80% of the stations at the packaging lines and 50% of the

• clerical tasks.

• Performs set-up, clean up and operation of manufacturing equipment such as filling, labeling and packaging Processes among others.

• Follows all safety rules regarding equipment/machine operation and proper guarding as well as maintaining safe and clean work

• environment by following organizational standards.

• Guarantee adequate equipment execution to assure that is performing as required, minimizing the opportunities of process defects or

• non-conformity events, also performs product/process inspections inn 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. Complies 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.

• Assures 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.

• 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.

• Acknowledge and maintain commitment with the environmental policy, and participate actively in the environmental programs to achieve

• established objectives and goals. Complies with environmental regulations related to handling of hazardous materials applicable to the

• area.

• Assures 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.

• 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 the filling station is operated efficiently and each lot delivers the expected yield.

Qualifications:

Language: Ability to read and understand English & Spanish

• Regulations:

• Basic cGMP knowledge

• Comprehensive knowledge of cGMP, FDA & EHSS regulations

Profession License or Certification Required: N/A

Technical Qualification & Other Background:

• Must posses 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

Mathematical Reasoning: Add, subs tract, multiply, divide and calculate percentages as well as able to use a calculator or other associated electronic equipment.

Basic cGMP knowledge

• Comprehensive knowledge of cGMP, FDA & EHSS regulations

• Ability to follow written procedures and/ or verbal instructions communications by telephone, fax or shortwave radios.

• Ability to read and understand English & Spanish

Specific Required Competencies by Role:

Individual Contributor Level I

Timely Decision Making, Information skills, Technical Learning

Education:

Essential: Vocational or High School Diploma

Job Experience:

• Essential: No experience required

US Benefits at Baxter (except for Puerto Rico)

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.