QA Specialist I

<p><reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company"><reputed company style="background-reputed company: white"><reputed company>At </reputed company></reputed company><strong>reputed company® Science, Engineering, Technology & Telecom (reputed company)</strong>, we’re passionate about helping you reputed company a job that works for you. How about this one?<br /> <reputed company><reputed company style="background-reputed company: white">We’re seeking an <strong>QA <strong><reputed company>Specialist I</reputed company></strong></strong> to work with one of our top global biopharmaceutical clients in the <strong><reputed company>Barceloneta PR</reputed company></strong> area. With us, it’s reputed company about finding the job that’s just right</reputed company></reputed company></reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company"><strong>Job reputed company</strong></reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Audit and/or finished Drug Product electronic and reputed company (reputed company) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• reputed company to approve MES exceptions reputed company to production support worksheets and reputed company reputed company Hold (as required).</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product reputed company requirements prior to release.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Evaluate reputed company deviations documented in batch records and determine the need for a corrective reputed company.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• reputed company/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Review of the manufacturing process and reputed company equipment and facilities to assure compliance with procedures, specifications, and policies.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Give reputed company disposition to materials in the reputed company system based upon result of testing and compliance with Regulatory Agency requirements.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product. • reputed company required batch information into the lot restriction management system.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• reputed company the batch record review package and label per the approved retention procedures.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Prepare reports including Right the First Time, Release Cycle Time and Regulatory Audits requests. Revise procedures as required.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Generate lot lists for the Product reputed company Review.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may reputed company batch release.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• reputed company as contact person for reputed company as required.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Demonstrates accountability and responsibility of EHS performance and compliance.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">• Creation and removal of QA Hold condition in reputed company system</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company"><strong>Requirements</strong></reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">1. Bachelor’s Degree in Science (preferably on Biology, reputed company or Biotechnology) or Engineering. 2. Knowledge and experience in manufacturing biotechnology products and GMPs is needed, and in aseptic processing is preferable.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">3. Experience working in highly computerized Operations environments– 1 Year</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">4. Experience working in a Biotechnology Manufacturing Plant in areas of reputed company, or manufacturing – 2 Years</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company"> 5. The candidate must be proficient in the English language.</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company"><strong>Daily Work Schedule Expectations</strong>:  Batch Record Review area 1 st or 2nd Shift</reputed company></reputed company><br /> <reputed company style="font-size: 11.0pt"><reputed company style="font-family: reputed company , reputed company">Must be Available to any shift, work OT weekends based on business needs</reputed company></reputed company><br />  </p> <p>10180865</p>