Quality Specialist - I (Assistant)
Client Overview
AgileOne incorporated in 1999 and headquartered in Torrance, California, is the Global External Workforce Solutions Provider for Merck & Company. Together we understand that growing what matters takes nimble teams that bring together talented individuals to solve problems quickly. Our contingent work opportunities are perfect for highly skilled professionals who want to make an impact without committing to a long-term employment relationship. When you join one of our projects, you’ll take on challenging work across our divisions in the United States.
All opportunities listed are temporary in scope as your employer would be AllSourcePPS, Inc., an affiliate of AgileOne. These assignments are temporary and "at will". There is no guarantee of on-going employment with AllSourcePPS, Inc. or any promise, expressed or implied, of conversion to employment with Merck & Co., Inc. We look forward to you starting your journey with us.
**For US Residents Only**
Role Description/Expectations
Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/ inspection role. Previous experience in project management, process data analysis. Lean Six Sigma Certification Previous Experience with SAP, Midas, or Trackwise.
Responsibilities
The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations. The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures and other quality related documentation. The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews. Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge. May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements. Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols. Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams. The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections. Must be flexible to accommodate this need.