Thousand Oaks, CA, 91358, USA
18 hours ago
Specialist Quality Assurance
**Duration:** **6** **months contract** **Job Description:** Quality Assurance Specialist - Global MES Projects The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic, results-oriented, and experienced Quality Assurance Specialist to join our organization as a Remote Worker. The candidate will be responsible for supporting the global Manufacturing Execution System (MES) projects and initiatives to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment. This is an excellent opportunity for a highly experienced and talented individual to contribute to client’s mission of serving patients. **Key Responsibilities** + Ensure quality oversight and compliance for MES and PT project activities. + Support validation and qualification efforts for computerized systems in alignment with GMP requirements. + Review and approve documentation related to MES workflows, change controls, and deviations. + Collaborate with cross-functional teams to ensure quality standards are met during system implementation. + Participate in risk assessments and support mitigation strategies for quality-related issues. + Ensure that quality processes and procedures are updated and aligned with project deliverables. + Provide training and guidance on quality practices and regulatory compliance. + Support audits and inspections by providing documentation and subject matter expertise. + Monitor and report on quality metrics and continuous improvement initiatives. + Ensure alignment with global quality standards and local regulatory requirements. **Basic Qualifications** + Bachelor's or Master’s degree in Life Sciences, Engineering, or related field. + Proven experience in quality assurance within a GMP-regulated manufacturing environment. + Experience supporting MES and process transformation initiatives. + Strong understanding of validation principles and regulatory compliance. + Excellent documentation and communication skills. + Ability to work collaboratively in cross-functional teams. + Detail-oriented with strong analytical and problem-solving skills. + At least 5 years of experience in quality assurance or related roles. **Top 3 must have skills:** + Hands‑on with PASX along with associated integrations to Level 2 and Level 4 systems. + Experience in designing, deploying, and maintaining Körber’s PASX MES system. + Pharma / GxP regulated‑environment experience. Ideal Candidate: B.S. 4-5 YOE. Prior pharma, GMP knowledge, and minimum 1-2 YOE working with the MES platform. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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