Quality Control Analyst

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At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We are Janssen.

Our mission drives us.

Our patients inspire us.

We collaborate with the world for the health of everyone in it.

**We are searching the best talent for **Quality Control Analyst ( 10 MONTHS **) to be in Sao Jose dos Campos.**

**Purpose**:
The QUALITY CONTROL ANALYST will cooperate with quality control activities associated to company’s project, ensuring internalization and deployment of quality requirements to the diverse processes of our supply chain.

**You will be responsible for**:

- Perform activities related to the validation of analytical methodologies for drug products and raw materials / process validation / analytical tests in general (chemical activities)
- Perform activities related to the validation of analytical methodologies for drug products and raw materials
- Development, review, and execution of analytical validation protocols
- Development and review of technical documentation and analytical validation reports
- Support other activities/projects related to the analytical area
- Structure and manage quality records. E.g: investigations, CAPAs, and risk assessments
- Ensure compliance with applicable regulations, standards and procedures
- Ensure compliance with Data Integrity
- Elaborate and Review documents at TRU according to methods transfers (protocol and reports)
- Perform the transfer timeline of execution
- Support other analysts of the project
- Perform deep dive in the methods to support equipment team
- Elaboration and review of technical documentation. (PATE, HMP, Technical Justification, Change Control Assessment and Risk Documentation)
- Update/ obsolete documents, procedures, and specifications
- Ability to communicate clearly with internal organization and global teams
- Collaborate effectively with project members, following priorities, checkpoints, and deadlines to support objectives
- Have the mindset to proactively find opportunities to improve our process.

**Qualifications**:
**Qualifications**:

- University degree in pharmacy, chemistry, chemistry engineer, or related areas.
- Minimum 2 years of work experience in quality control laboratory or analytical development.
- Knowledge of physicochemical analyses: liquid and gas chromatography (HPLC ad CG), UV/IR spectroscopy, dissolution techniques, and others.
- Good organization skill with ability to meet deadlines
- Intermediate English (speak, written and listening)
- Knowledge of the main pharmaceutical legislation (RDC 166/2017, RDC 73/2016, RDC 443/2020, RDC 53/2015, RDC 318/2019).
- Quality processes and tools knowledge nonconformance, change control and laboratory investigations.
- Empower and eLIMS experience.