28 days old

Quality Associate

Kelly Services
Jayuya, PR 00664
Kelly Services is currently seeking a **Quality Associate I** for one of our top clients in **Jayuya, PR**

**Full Time Exempt Position |** **Salary: $19.20/hr**


Provides technical support, and coordinates activities and projects for the NCR/Complaint System, assuring compliance with established standards and regulations. Creates, improves and audits SOPs to assure that NCR/Complaint System is in compliance with all internal specifications and regulatory requirements. Serve as a point of contact for the tasks tracker and report management.


+ Responsible for leading the NCR/Complaint System and the Quality System tracker at the Facility.

+ Prepare quality reports, quality indicators and accountability item to track progress and measure improvements in the NCR/Complaint System.

+ Manage the Certification (Change Document Review) process for the NCR/Complaint System and areas of responsibility.

+ Responsible for the preparation, evaluation and/or escalation of immediate situations related to the NCR/Complaint System.

+ Assure compliance with company procedures, quality and regulatory requirements, and guidance including QSR, cGMP, USP, regulations and guidelines. Ensure readiness of the Plant for audits internal and external. Serve as a technical expert and interface with investigators during both internal and external inspections. Support FDA readiness plan.

+ Prepare, review and revise, as required, local SOPs and specifications. Audits, creates and implements changes to specifications and SOPs. Write memos, reports, protocols, and other appropriate documentation for proper functioning of the areas.

+ Prepare and document the Management Review and Quality Data Review with regards to NCR/Complaint System data and Quality tracker or other as requested.

+ Manage and use Applicable Software applications.

+ Perform changes to procedures to areas of responsibilities.

+ Coordinate, participate and perform communication, meetings or teleconference with company departments or facilities, as required.

+ Fill out, files and controls all related documentation for areas of responsibilities assuring the compliance with standards and company retention requirements.

+ Support other department, as required. Able to communicate at all Plant levels.


+ Bachelors degree (B.S.) in Sciences, Engineering or Business Administration with one (1) to two (2) years of experience in pharmaceutical/medical devices operations or Master's Degree in Science, Engineering or Business Administration without experience.

+ Fully bilingual (English and Spanish). Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, internal or external audits and other departments.

+ Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

+ Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

+ Able to work within minimum supervision.

+ Able to work at any shift when is required. Occasionally required to work extra hours, Holidays (e.g. shutdowns, FDA Audits, ISO 9001 Audits, Pharma Partner Audits and Due Diligence Audits).

+ Team worked oriented.

+ Able to prepare and/or provide training, when required.

**Why Kelly?**

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay

+ *Holidays paid and Christmas bonus*

**Apply Today!** at

_*_ _Must comply with minimum established requirements to qualify._

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at
Posted: 2019-11-08 Expires: 2019-12-09

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Quality Associate

Kelly Services
Jayuya, PR 00664

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