Quality Assurance Specialist Ii

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.  We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people's lives with our health care products.

The Quality Specialist provides support for the business' product development portfolio and ensures adherence to CGMP compliance in a regulated environment. Support the Manager of R&D Quality who is responsible for the effective management of the quality oversight and delivery of quality services supporting product development. The role is instrumental in supporting Right-first-Time (RFT) culture in New Product Introductions (NPI). As such, it requires effective collaboration with multi-disciplinary internal and external teams in driving adherence to Quality-by-Design principles as well as compliance with relevant regulatory requirements and corporate standards.

Experience:

• 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

Qualifications:

• 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

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

#LI-hybrid

This position may be available in the following location(s): US - Bridgewater, NJ

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com  or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

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