Johnson & Johnson Quality Control Job – Officer Post Vacancy

Johnson & Johnson Quality Control Job – Officer Post Vacancy

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Job Title: Officer, Quality Control

Req Id: 2105956047W

Qualifications

• Education: Graduate or Postgraduate in Chemistry / B. Pharm / M. Pharm.

• Experience: Minimum 2 to 5 years of experience in QC function/ Instrumentation Section.

Technical Skills / Behavioral Skills

Functional competencies:

• Knowledge of GxP Documentation and of the following areas like Test Method and Specification, Instrument operation procedure, current regulations. Departmental SOP’s, Report writing / Data analysis, OOS / NC procedures, and Data Integrity issues.

• QMS: In-depth knowledge of tools for the investigation of OOS / NC, Audit trail reviews, and capabilities of analyzing its impact assessment.

• Cross-Functional coordination: Coordination skills with all stakeholders.

• Instrumentation and Analysis: Overall knowledge of Instrumentation and analysis.

• Qualification and Certification: Process experience. Overall knowledge of Product / Business priorities / Projects. Authority of decision-making base on facts. Overall expertise in elements of one

section of Technical Competency, leading in Fundamental skills, Professional skills & Behavior skills. Must be expert for Supervision & process knowledge.

Job Summary

Plans, coordinates and perform routine and complex testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of the product to customers.

• Plan, co-ordinate, and execute activities of Quality Control, Instrumentation Section including HPLC, GC, UPLC, . Finished Goods activities to ensure continuous production of products consistent with established Quality & Regulatory standards by performing the assigned duties and responsibilities

Responsible for the day-to-day management of the quality laboratory tests, logbook review, compliance to the applicable procedure. The Analyst will ensure that product testing is completed in a timely and compliant manner and support in troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis as required. In addition, the Analyst will support and execute in collecting, collating, and documenting laboratory metrics for presentation to management.

Duties & Responsibilities: 

Under general direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Performing routine and complex testing in compliance with laboratory test methods and procedures to support the manufacturing & timely delivery of the product to customers.

• Applicable Compendia testing.

• Quality Control testing, reports review when thorough training has been completed under the guidance of a supervisor.

. Knowledge and experience in Empower system.

• Initiation and participation during investigations for non-conforming laboratory test results.

• Collecting and preparing laboratory records for evaluation following good documentation practices.

• Troubleshooting methodology or instrument problems

• Communicating business related issues or opportunities to their immediate Supervisor

• Operating in accordance with current GxPs with regard to documenting, testing and maintaining accurate laboratory records.

• Support in QC lab Projects, Change Controls, Actions and Effectiveness Monitoring.

• Performing calibrations and annual maintenance of laboratory Instrument life cycle management according to current SOPs.

• Assisting in various other duties which contribute to the organization and function of the laboratory, and as assigned by supervisor

• Ensuring personal and company compliance with all local and company regulations, policies, and procedures for Health, Safety and Environmental compliance.

• QC test Data Timely Archival and retrieval.

• Ensure all time audit readiness and 5S in Quality Control Lab.

• Test method validation and test method life cycle management for Chemical test methods.

Handling and support for Audit.

• Chemical -safety, Chemical-hazard management

• Assures that all QC tests activities run in a safe, clean, and environmentally sound

• Manner.

• Ensure timely validation & Calibrations of Instruments in QC laboratory under the guidance of a supervisor.

• Formulates and meets QC objectives and coordinates objectives and priorities

• with operations.

• Trending and analysis of statistical data related to QC activities to determine

• present standards and establish proposed quality and reliability expectancy

• Carries out duties in compliance with all regulations and guidelines including MDR and Food & Drug

• Administration (FDA). Complies with all company and site policies and procedures

• Follows all applicable aspects of the site environmental management system

Compliance & Training

• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority.

• Complies with all training requirements to perform duties of the job.

• Ensure adherence/compliance to Records Management policies and procedures, as applicable.

Accountability:

• Maintained 5S in the laboratory, GLP in the laboratory.

• Instrument spare management. Gas cylinder inventory & management.

• Status Labelling.

• Overall Instrumentation of lab Accountability.

Apply Online

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