Job Information
Integra LifeSciences Coordinator, Product Release in Anasco, Puerto Rico
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Prepare logs of Product Release, Releases Turnover. Orders and holdbacks of products that do not meet all requirements for further processing or shipping until corrective action has been taken. Performs the final review of shop orders for completeness and accuracy and assures all required documentation such as Lab and sterilization results are attached. Takes corrective action to resolve discrepancies on shop orders personally or requests information or documents needed to fulfill the requirements for product release.
Maintains traceability of items in plant to determine status or access information required to support management decision making or provide information requested by other personnel.
Communicates with corporate office and co-release customer, to attend details and inquire other information.
Develops and implements computerized systems that provide readily accessible and reliable historical information of Device History Records and products status in plant.
Perform transaction (Work Order Release) on Oracle system.
Prepare and verify product certification.
Prepare End of Month Report.
Updates procedures of the area of responsibility as required.
Assures Device History Records, Engineering and Quality Assurance documentation are maintained for required periods of time.
Maintains files of Device History Records under control and always organized.
Maintains logs organized, update and accurate to provide valid and reliable information to requisitioners from Quality Assurance, Manufacturing, Accounting and Shipping Dept.
Notifies Supervisor when any situation can affect the accuracy and reliability of Device History Records or existing deficiencies that require attention to protect the quality of historical records and compliance of production schedules.
Provides data as required for audits/regulatory agencies.
Performs other related duties as requested by the Supervisor.
DESIRED MINIMUM QUALIFICATIONS – Education and Experience
The requirements listed below are representative of the knowledge, skill and/ or ability required for this position.
High School degree required.
Associate Degree in Sciences or Business Administration preferred.
A minimum of two (2) years of experience in an FDA regulated manufacturing environment with exposure to production documentation and Quality Assurance function or equivalent experience in a similar position.
Proven knowledge of manufacturing processes, product lines, GMP's, and FDA regulations.
Knowledge of personal computers and terminals.
Strong interpersonal and communications skills
Fully Bilingual
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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