Quality Compliance Job Listing at Kelly Services in Manatí (Job ID 9633853)

Description

Kelly® Science & Clinical is seeking a Quality Compliance for a 8 month contract position at a Global Pharmaceutical client in Manati, Puerto Rico.  If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $37.48  per/hour

Overview

This client is Global Biopharmaceutical companywhose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

In this role you'll be responsible for maintaining several elements within the Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and company policies.

This role will give you an opportunity totransform patients' lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation.

Schedule: First Shift - 8am-5pm

Responsibilities:

• Acknowledge conducts and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses.
• Supports readiness of the facility for Regulatory Inspection.
• Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits.
• Documents any FDA communication between Site and agency.
• Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit.
• Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency.
• Create, review approves and track corrective actions related to internal and external audits.
• Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
• Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
• Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP's trends.

Qualifications:

• Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.
•  Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry or medical device.
• Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
• Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
• Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and

What happens next:
 
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

 Apply on company website