12 days old

Quality Assurance Plant Support Specialist

Kelly Services
Humacao, PR 00792
**Quality Assurance Plant Support Specialist**


This position is responsible for the online review and Quality Events investigations associated to all manufacturing and packaging process ,batch records and; approve from Quality standpoint process related documentation for assuring that manufacturing activities are carried out within the framework of corporate/governmental policies and regulations (cGMPs). The position will have the Subject Matter Expert (SME) role from the Quality perspective to provide guidance and coaching to different areas / department. 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 Humacao site. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations. Opens notice of event (NOE) in the Trackwise system for any detected incident, deviation or documentation error during the batch record review process. Assures that 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 CAPAs 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. Provides advice and service to all operating departments as to assure compliance with cGMPs and other regulations. (This includes frequent feedback on performance regarding deviations, rejections, complaints, outstanding commitments, trends, etc.). Conducts and documents GMP and/or SOPs training as required. Reconciles the materials used for the manufacturing of each product stages using the SAP transaction MB56 and report any discrepancy. Evaluates inventory frequently to drive closure of pending items to assure timely disposition. Assists in the Supplier Qualification/Certification program. Performs readiness exercises for government inspections. Assists in the material / Lots disposition when required. Maintains actively communication with other site Quality and Operational areas to keep lot status posts and drive timely resolution of quality issues.


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 CAPAs. Fully Bilingual (Spanish/English).

Available to work rotating shifts, extra hours and on weekends.

**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. (
Posted: 2022-06-13 Expires: 2022-07-14

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Quality Assurance Plant Support Specialist

Kelly Services
Humacao, PR 00792

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