Quality Assurance Consultant
Your tasks and responsibilities
The primary responsibilities of this role, Quality Assurance Consultant, are to:
- Independently review Good Practices (GxP) Document Deliverables as a Subject Matter Expert (SME), approving/authorizing key documents such as User Requirements Specification, Quality Assurance Agreement, Validation Plan, Risk Assessment, Test Protocols / Reports, Validation Summary Report, and releasing systems into production;
- Provide regulatory advice to projects, participate in CSV Audits as a SME, support inspections, increase quality, and optimize review and approval timelines;
- Ensure GxP document deliverables are consistent and in compliance with site and corporate policies and procedures following Food and Drug Administration (FDA) & European Union (EU) Regulations, and facilitate a Risk-Based Lifecycle Approach from Business Process Description through System Retirement;
- Guide in System Validation, Data Integrity, Code of Federal Regulations (CFR) 21 Part 11 Compliance, Audit Preparation and Support, Data Migration, and Release and Change Management Processes;
- Work closely with business stakeholders and technical support groups to thoroughly investigate validation discrepancies, drive deviation management, and create best-practices for system validation including Computer Systems Validation (CSV) training and workshops;
- Be willing to travel both nationally and internationally.
Domestic Relocation Assistance is Available as well as sponsorship for a Visa for an individual that is currently in the US and is the the greencard process.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor’s degree in statistics, applied mathematics, data science, computer science, or related areas with at least 10 years’ of IT experience OR Master's degree with at least 8 years’ of IT experience OR Doctorate with 1 or more years of IT experience OR 12 years of combined education and IT experience can be substituted;
- Five to ten years of proven experience with IT compliance regulations, quality management, and computerized system validation especially for Research & Development (R&D) preferred;
- Experience in the implementation, validation, and Quality Assurance (QA) of stand-alone IT solutions as well as complex enterprise systems such as Oracle LSH, RAVE, and Clinical Systems;
- Technical proficiency, attention to detail, creativity, innovation, and independent thought;
- Good communication, interpersonal, and technical writing skills across all organizational levels as well as strong analytical/decision making skills, and proficient computer skills;
- Must be conscientious, dependable, embrace change, and work effectively with a global/culturally diverse team;
- Candidate must be self-motivated/self-starter, will work independently with little direction on routine assignments and collaboratively to facilitate solutions to complex problems of diverse scope where a solution is not readily apparent;
- Strong commitment to quality and continual improvement of software development processes, implementation of best practices, and the use of software tools.
- Experience with Document Management Systems (such as Documentum) and software tools (such as HP-ALM / Quality Center, ValGenesis, Collaboration Environments such as Microsoft SharePoint© and Teams).
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Location: NJ-Morristown, NJ-Whippany