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 company whose 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 to transform 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.

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