Global Pharmaceutical Quality Assurance Specialist

hace 1 mes


Manatí, Puerto Rico Kelly Services, Inc. A tiempo completo

About the Role

We are seeking a skilled Quality Compliance Specialist to join our team at Kelly Services, Inc. in Manati, Puerto Rico.

Job Description:

The selected candidate will be responsible for maintaining quality systems and ensuring compliance with Good Manufacturing Practices (GMP) regulations and company policies.

Key responsibilities include:

  • Acknowledge and approve investigations for customer complaints, regulatory corrective actions, and vendor certifications
  • Support facility readiness for regulatory inspections
  • Assist in audits during regulatory agencies inspections and internal company audits
  • Document FDA communications between site and agency
  • Conduct internal and external audits with respective reports and action items
  • Create, review, and track corrective actions related to audits
  • Prepare and submit reports on assigned quality systems status
  • Provide GMP training and support to other departments as needed
  • Develop and implement departmental procedures and forms to ensure compliance

Requirements:

To be successful in this role, you should have a Bachelor's degree in Chemical, Engineering, Biology, or Microbiology Science, along with 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 are also necessary to prepare trends analysis, investigation reports, and regulatory and internal audits responses.

Compensation and Benefits:

We offer an estimated salary of $37.48 per hour, which translates to approximately $77,767 per year, based on a standard full-time schedule.

As a Kelly employee, you will have access to various benefits, including voluntary benefit plans, retirement savings plan, service bonus, holiday pay, and more.

About Us

Kelly Services, Inc. is a leading science and clinical recruitment agency that connects top talent with premier companies. We pride ourselves on creating expert solutions to solve the world's most critical challenges.



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