Manufacturing Support
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Key details
- Location
- Cayey, PR, United States
- Work style
- Onsite
- Level
- Mid level
- Job type
- Full-time
- Function
- Skilled trades & Manufacturing
- Focus area
- other
- Posted
- 4d ago
Skills
control systemsengineering change ordersexcelgmpleanmicrosoft officemicrosoft wordpowerpointword processing
About the role
We are looking for Manufacturing to support the manufacturing areas in the implementation of document changes through the Engineering Change Order (ECO)
systems. Assists in writing and reviewing departmental procedures and is also responsible for the expeditious processing
of new SOP's, tracking and initiating Engineering Change Orders and securing completed documentation for all
manufacturing areas. Assists in manufacturing data collection and metrics. Supports CI Initiatives as requested.
Support the manufacturing areas in the implementation of document changes through the Engineering Change Order
(ECO) systems.
Ensure documentation changes related to Capital/Validation projects, Quality Notifications or CAPAs are implemented
in a timely manner not to impact project timeline or due dates.
Active participation in CI/Lean Activities.
Assists in manufacturing data collection and metrics.
Responsible for the creation of SOPs, manufacturing batch records and other GMP required documentation for the
manufacturing areas by formatting and word processing, as needed.
Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.
Participates as required in training on regulatory issues affecting his/her working area. Brings regulatory compliance
questions/issues to the attention of management.
Promotes a safe work environment. May provide recommendations on maintaining the safety of the work
environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a
hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
Provide recommendations to support systems that continuously improve product/process quality and product
availability, reduce cost, and increase production capability.
Other duties as assigned, such as, but not limited to management of deviation records and periodic review of
documents.
Perform other related duties and assignments, as requested by management.
Requirements
BS Engineering
Knowledge on Documentation Control Systems.
Demonstrated ability to perform detail-oriented work with a high degree of accuracy.
Demonstrated ability to follow established policies and procedures.
Effective skills on interpersonal relationships, written and oral communication, planning/organization, time
management, and proactive participation.
Proficiency in the use of Personal Computer, scanner and office related equipment.
Proficiency on MS Office (Word, Excel and PowerPoint).
Knowledge of current business systems and application software (MS Office or equivalent)
Must be capable of independent work; a self-starter, highly motivated and able to work with minimal supervision.
Fully bilingual (English and Spanish).
Attendance and punctuality are an essential function of the job position.
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