QA Data Specialist
About The Position
MedTech Surgery Puerto Rico is recruiting for a QA Data Specialist, located in San Lorenzo, Puerto Rico. This role will report to Quality Team Leader, Quality Operations Leader, Quality Operations Lead or designee and with the objective of maintaining high quality standards for the product manufacturing process and the compliance with the regulatory requirements. Supports and maintains quality data in our system, performs data analysis and performs other functions to support the Quality Assurance Department at Ethicon LLC. Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Main point of contact and Subject Matter Expert for the Site’s Inventory Control System (ERP System, i.e. SAP) from a Quality Assurance perspective. Works closely with the ERP users, including key business functions to ensure up to date and accurate data in our ERP systems.
Requirements
- Associate Degree with 4 years of experience within the Quality Department in regulated industry or Bachelor’s Degree (Science or Technical Field preferred) with 2 or more years of experience within Regulated Industry.
- Knowledge in ERP systems for quality data process
- Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays.
- Intermediate or higher computer skills and use of software application(s).
- Bilingual (Spanish & English)
- Excellent organizational, time management and interpersonal and follow up skills.
- Able to communicate effectively with multiple levels of the organization.
- Knowledge of QSR and ISO Standards.
Nice To Haves
- Knowledge in SAP system transactions and functionality.
Responsibilities
- Manage QA Data within ERP System. Transactions performed by this resource will be the following (but additional transactions may be performed): Manage transactional Issues to move/transfer material to inventory.
- Perform corrections or changes in manufacturing and/or expiration date of Finished Goods Lots and/or raw materials, in accordance with procedures.
- Perform corrections to Finished Goods lots including reclassification, batch status changes, among others.
- Inspection Lot issues/Cancellation of Inspection Lots.
- Manage Subcon Report Issues.
- Execute Wind-shuttle templates, conducting SWFT Tickets, and execution of task as Ethicon QA Data Departmental Lead (DDL).
- Create tickets for Adding/Removing Accesses to ERP system.
- Conduct training to new users in the ERP process and/or procedures.
- Execute validations for ERP process enhancement.
- Execute material hold control process in ERP systems required.
- Submit changes and support implementation of changes in the documentation system.
- Support the effective implementation of programs that help improve the overall quality of product and process within area of responsibility.
- Support internal and external audits.
- Maintain knowledge of all procedures, changes to specifications and new regulations related to the area of responsibility.
- Maintain control of nonconforming raw materials, following applicable procedures.
- Support Plant operations in solving quality data issues affecting the supply chain process.
- Keep records of all performed tests following GDP and GMP procedures.
- Perform other duties as required by department leaders as needed.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
