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5 days old

Quality - Manager - Compliance

Kelly Services
Manatí, PR 00674
**Quality - Manager - Compliance**


This position is 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 policies.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.


Requirements:


Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science. Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry. Fully Bilingual (Spanish/English) communication skills, both written and verbal are required. Strong knowledge of relevant GMP, FDA, EU regulations. Expert in the interpretation and application of regulations according with the intended use.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-24 Expires: 2021-12-25

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Quality - Manager - Compliance

Kelly Services
Manatí, PR 00674

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