Job Description

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopaedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.

As pioneers in our industry, we continually focus on elevating the standard of care-working to expand patient access, improve outcomes, reduce health system costs and drive value. We create people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.
JOB SUMMARY

• Plans and coordinates Quality control activities to ensure continuous production of products consistent with established quality & regulatory standards by performing the assigned duties and responsibilities.
• The analyst/Officer is responsible for the day to day testing in the quality laboratory. To ensure product testing shall complete in a timely and compliant manner. The analyst work with supervisor and responsible for working with staff to troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis or Conformance as required.

DUTIES & RESPONSIBILITIES*

• Performing with competence, upon training, routine testing and Review of following laboratory test methods and procedures.
• End to end responsibility of stability Batches
• Developing a competence, upon training, in the use of laboratory instruments and equipment\'s.
• Performing calibrations and annual maintenance of laboratory Instrument life cycle management according to current SOPs.
• Working in compliance with current GxPs regarding documenting, testing and maintaining accurate laboratory logbooks and test data sheets.
• Initiation and participation in laboratory investigations of non-conforming, lab incident laboratory test results.
• Collecting and preparing laboratory records for evaluation following good documentation practices.
• Ensuring personal compliance with all, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Performing other related duties as assigned by the management.
• Testing of Finished product, raw material, packing material, stability, validation and In -process samples.
• Support to test method validation and test method life cycle management for chemical test methods.
• Chromatographic analysis and review.
• Act as a reviewer role for Finished good testing, In-process, validation Raw material and packing material testing as and when required.
• HPLC & GC column usage and maintains. HPLC, GC and UPLC calibration /validations and test method validations. Support in new analyst qualification.
• Testing of all FG\'s as per instruction of supervisor and support in timely releases of FG.
• Responsible for timely testing and release of FG, e.g. HPLC tests, GC test, UPLC test and all other FG tests.
• Destruction of samples.
• Communicating business related issues or opportunities to their immediate Supervisor. Perform work/ activities as assigned by supervisor.
• Operation of Empower, maintain audit trail. Timely submission of reports and audit trails for review.
• Preparedness for announced and unannounced audits.

Compliance & Training

• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and advised any violation or deviation to the immediate supervisor or appropriate authority.
• Aligns with all training requirements to perform duties of the job.
• Ensure adherence/compliance to Records Management policies and procedures, as applicable.

Accountability:

• Maintained 5S states of laboratory, GLP & GMP in laboratory.
• Reagent & Volumetric solution preparation and handling.
• Chemical stock inventory and management.
• Instrument spare & inventory management.
• Instrument status labeling.
• Overall instrument room and wet chemistry laboratory accountability.
• Mobile phase labeling.

EXPERIENCE AND EDUCATION

• Education: Graduate or Postgraduate in Chemistry/ B. Pharm/ M. Pharm.
• Experience: Minimum 2 to 6 years of experience in Chemistry function and Analytical instruments (like HPLC/GC/ UPLC/ UV/ FTIR preferable) handling.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Technical Skills / Behavioral Skills

Functional competencies:

• Knowledge of GxP Documentation and of following areas like Test Method and Specification, Instrument operation procedure, current regulations. Departmental SOP\'s, Report writing / Data analysis, OOS /OOT NC procedures and Data Integrity issues.
• QMS: In depth knowledge of tools for investigation of OOS / NC, Audit trail reviews and capabilities of analyzing its impact assessment.
• Cross Functional coordination: Coordination skills with all stake holders.
• Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.

Professional Competencies

• Operational Excellence: Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
• Quality & Compliance: Quality Approach, Compliance Orientation, Environment Health & Safety
• Business Partnering: Influencing, Change Management, Time Management, Global Approach & Management

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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