18 days old

Quality Assurance Batch Record Reviewer

Kelly Services
Humacao, PR 00792
**Quality Assurance Auditor - Scientific - Batch Record Reviewer**

This position is responsible for the on line /off line review and approval, from Quality standpoint, of manufacturing batch records associated to all manufacturing and packaging process. Review and approval of process related documentation such as Log Books, Cleaning Forms within others and overlook manufacturing activities to assure that are carried out within the framework of corporate/governmental policies and regulations cGMP s . 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. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough triage stage. Opens QE in the Trackwise system for any incident or deviation detected during the lot manufacturing process or batch record review process. Assures that Quality Events QE are evaluated within the established time frame provided in site procedure. Recommends material or product disposition, if required. Evaluates procedures, recommends and submits changes when necessary.

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 . Ability to communicate effectively with wide range of personnel, written and verbal.

**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: 2020-11-16 Expires: 2020-12-17

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Quality Assurance Batch Record Reviewer

Kelly Services
Humacao, PR 00792

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