Quality Assurance Specialist II
Bausch Health
- Bridgewater, NJ
- Permanent
- Full-time
- Partner with cross-functional project team in the development, review and approval of relevant CMC documentation that supports science driven process knowledge and understanding, risk management principles while remaining agile and customer centric approach.
- Review and approve Quality-by-Design principles documents such as TPP/QTPP, RA Strategy Document, Critical Material & Quality Attributes, Critical Process Parameters, Control Strategy etc.
- Facilitate GMP launch readiness activities, such as:
- Stage gate reviews for validation, launch, etc.
- PAI or other inspection readiness plans o Submission review •Review and approve GMP documents (e.g., production batch records, lab batches, API and raw materials, product specifications, analytical and micro work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ. PQ qualifications and equipment calibration).
- Review and approve deviation and OOS investigations.
- Review and approved method transfers.
- Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.
- Ensure timeliness and integrity of work. • Understand technical procedures and be able to verify accuracy of calculations.
- Support new product development and CMO activities for both consumer and Rx products.
- Review and release labelling jobs.
- Review and release finished product clinical trial materials manufactured by CMOs.
- Support/lead knowledge transfer from development to commercial quality team
- Support development teams from a technical, regulatory, and quality perspective to meet the regulatory requirements and the appropriate standards: ICH, USP, EP, JP, etc.
- Partner/team with stakeholders across the organization to address compliance related issues and processes
- Support/lead the development of risk management plans, risk assessments, to support new product development
- Define and develop the quality strategy for the lifecycle management of the project (Quality plan/quality strategy)
- Perform other duties assigned by the Manager R&D Quality and Quality Leadership as required
- Bachelor's Degree in scientific discipline such as chemistry, pharmacy, engineering. Advanced degree in similar field preferred
- Prior experience in a GMP quality (Manufacturing/QA/QC) environment, experience in drug substance, drug product and final packaged product a plus
- 2-5 years of relevant life sciences quality experience within quality and/or quality-related functions
- Experience working with contract manufacturing organizations and driving process improvements
- Prior experience in disposition of clinical products
- Strong Knowledge of applicable US and Global compliance regulations and industry practices regarding cGMPs
- Strong knowledge and demonstrated practice of ICH Guidelines.
- Exceptional attention to detail. Outstanding written, verbal skills and problem-solving skills. Strong computer skills, including all MS Office applications. Effectively interact with multi-disciplinary functional groups. Exercise sound and independent judgment and decision making.
- Ability to work in a fast-paced, dynamic environment.
- Previous experience in application of QbD, and/or Lean Six Sigma is a plus