Quality Assurance Plant Support Specialist

This position is responsible to Oversee shop floor manufacturing activities by being present during manufacturing activities in order to provide SME quality guidance and/or approval to ensure full compliance with cGMP’s and other regulations.
Reviews and approves the executed batch records pertaining to the preparation, formulation, granulation, compressing, coating and printing or any additional stage (e.g. inspection) of the final dosage form of all products manufactured in the site.
Identifies improvements in the working area related to documentation design and flow to the process area. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations.
Assures that Site Quality Events (QE) are completed within the time frame provided in site procedure. If time extension is required, assure timely submission of required documentation.
Evaluates and approves investigations and CAPA’s for returned goods, damaged goods, process deviations and laboratory investigations.
Reviews Quality Events Reports performed by operational areas to assure that Root Cause was identified, adequacy of correctives and preventives actions taken and proposed, report redaction and format is adequate, clear and in compliance with procedure. Recommends material or product disposition, if required. Evaluates specification, recommends and submits changes when necessary to the specifications committee. Reviews and approves completed CAPAs.

MINIMUM REQUIREMENTS
• Bachelor in Science (Microbiology, Chemistry, and General Sciences), Engineering or Pharmacy.• Five (5) years of experience in Pharmaceutical Manufacturing Industry with exposure to Quality and Manufacturing field.• Broad knowledge on Quality Systems such as Change Control, Investigations and CAPA’s.• Fully Bilingual (Spanish/English). • Solid technical writing skills related to investigation reports
*Available to work rotating shifts, extra hours and on weekends.

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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 ?). 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.