30 days old

Operations Process Compliance Specialist

Kelly Services
Humacao, PR 00792
Operations Process Compliance Specialist

This position is accountable for timely investigational processes within Site OSD manufacturing operations and; for the corresponding timely implementation and effectiveness of Corrective and Preventive Actions (CAPA) plan. Also accountable for ensuring investigations are performed within the standard scrutiny of governing compliance bodies. The incumbent of the position must comply with all Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Executes and ensures that all Quality Events (QEs) and CAPAs are completed / closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence. Monitors and assures that action plans have been implemented to eliminate reoccurrence. Reviews and provides input to regulatory submissions applicable to area of responsibility.Interacts with regulatory compliance agencies with respect to Quality Events.


BS Degree in Science, Pharmacy or Engineering Five (5) years of experience in an Oral Solid Dosage Manufacturing facility. Strong technical writing and presentation skills Experience in root cause analysis methodologies Ability to interpret and analyze statistical data Operational and scientific investigation expertise Knowledge in cGMPs, OSHA, EPA and other regulatory standards Knowledge of computers applications (Microsoft Word, Excel, Power Point) Excellent interpersonal skills and team work oriented Excellent communications skills in Spanish /English

**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-24 Expires: 2020-10-24

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Operations Process Compliance Specialist

Kelly Services
Humacao, PR 00792

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