Documentation Clerk job in Cayey
Vacancy has expired
Cayey CorTech LLC
| Job Ref: | 346293 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 15.00-15.00/Per Hour |
| Remote: | No |
Location |
|
| City: | Cayey |
| Post Code: | 00736 |
| Map: |
|
Description |
|
|
Support the Quality System Specialist - Documentation and Data Management in the implementation and maintenance of the organization?s Document Control and Engineering Change Order (ECO) systems. Interfaces with users of controlled documentation to ensure internal customer satisfaction and conformance to regulatory standards. Assists in internal and external audits retrieving requested documentation, assist 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. Assists in the maintenance of the plant quality record filing. Receives instructions from the Quality Manager, Associate Quality Manager, Quality Supervisor and Quality System Specialists on routine work and on new assignments. DUTIES AND RESPONSIBILITIES ? Assists the Quality Specialist in the execution of the Document Control and Engineering Change Order (ECO) systems activities in accordance with GMP and quality standards. ? Maintains and coordinates documentation as required by the manufacturing facility such as Device Master Records, Device History Records, Customer Complaint Records, Forms Control System, Calibration Records, and other documentation activities as required. ? Assist in maintaining, controlling, verifying, and ensure ECO's are processed using electronic system is accurate and in a timely manner. ? Performs quality record scanning and maintains electronic filing system per internal customer requirements. ? Maintains controls, verifies, and ensures SAP database implementation of Engineering Change Order (ECO) incorporation is accurate and completed in a timely manner. ? Maintains numbering systems for new and revised quality system documentation. ? Supports the creation of SOPs, manufacturing batch records and other GMP required documentation by formatting and word processing, as needed. ? Maintains an accurate Master Record filling system. ? Ensure that all batch records are completed, and filed. ? Assist in the review of documents for completeness and accuracy. ? 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. ? Interact with all disciplines at BDB Cayey, other BDB plants and BD affiliates. ? Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability. ? Perform other related duties and assignments, as requested by management (e.g. Metric Maintenance/Reporting). MINIMUM QUALIFICATIONS KNOWLEDGE AND SKILLS ? Knowledge of current regulatory requirements for pharmaceutical/medical devices industry. ? 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. Document: JD-QA-009- FLSA STATUS: Non-Exempt ? 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. ? 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. EDUCATION AND EXPERIENCE Requires at a minimum an Associate Degree or equivalent with a minimum of one (1) year of experience in documentation control system in a FDA & ISO regulated environment. SUPERVISION MENTAL DEMAND Apply commonsense understanding to carry out detailed written or oral instructions. Manage stressful situations. PHYSICAL DEMAND The work requires lifting, carrying, pushing and pulling of light weight level objects. In addition, occasionally requires standing, walking, reaching, seeing (far vision and depth perception). Frequently, the job requires sitting, handling, fingering, talking, hearing, seeing (visual color discrimination) and constantly requires seeing (near vision). WORKING ENVIRONMENT The work is performed constantly inside the building. Does not present risks and discomforts in the employee's physical surroundings. BD04123JD | |
ref: (346293)
1045 days ago
Back to search results