Quality Assurance Compliance Associate III

Company: Rentschler Biopharma SE
Location: Milford
Posted on: March 16, 2023

Job Description:

About Rentschler Biopharma Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharmas high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. To offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with 1,000 employees. Job Summary We are recruiting for a proactive, strategic, and "hands-on" Quality Assurance Compliance Associate III. They will demonstrate flexibility, adaptability, and effectively work in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task, while delivering excellent customer service. Join our team built on collaboration and respect, supporting one another in our work to provide reliable, efficient, and progressive technologies and people-first services to our Rentschler community. Through honest feedback and teamwork, we continuously improve our work and capabilities to optimize and innovate for the success of our business. The Quality Assurance Compliance Associate III is responsible for all activities related to compliance process. This individual is responsible to support client facing deliverables, customer communications and assist in regulatory commitments. Coordinate efforts globally for harmonization of inspection readiness compliance for the site. Duties and Responsibilities

• Provide Quality and Regulatory support for clients for authority / agency inspections and audits
• Inspection Readiness Activities for current and new health authority (PAI) inspections
• Internal Audit program and regulatory inspections
• Support client audits and regulatory authority inspections with Subject Matter Experts and key stakeholders.
• Interface with Audit team and represent the company during Audits
• Work cross site with Global Regulatory team to ensure authority deliverables are met to maintain compliance
• Provide inspection support for the timely delivery of documents, provide coaching for subject matter experts for inspection readiness, and review information into the inspection's rooms for compliance
• Support Audit responses
• Participate in due diligence visits with clients
• Support quality compliance initiatives:
• Work cross functionally to perform gap assessments for global procedures, identifying compliance improvements and efficiencies
• Collaborate in procedural and process changes.
• Implement and drive the Compliance Improvement Plan initiative items
• Support client facing communications and notifications
• Implement and drive the Compliance Improvement Plan initiative
• Support close out of change controls and CAPAs resulted from Audits or inspections.
• Support training program related to Audits and inspections
• Support Data compliance as required Qualifications
  • Bachelors degree or 5+ years related experience
  • Excellent working knowledge of GMPs, including interpretation and application of regulations across pharmaceuticals and biologics
  • Strong communication skills, both orally and written.
  • Strong organizational and time-management skills, with ability to work to timelines and meet project milestones Working Conditions
    • Regular office working conditions Physical Requirements
      • Personal Protective Equipment must be worn as required Direct Reports
        • N/A

Keywords: Rentschler Biopharma SE, Worcester , Quality Assurance Compliance Associate III, Other , Milford, Massachusetts