(QC450) - Associate Analyst - Quality Control

(QC450) - Associate Analyst - Quality Control

13 Sep
Johnson & Johnson

13 Sep

Johnson & Johnson


Position: Associate Analyst - Quality Control

Location – Higi, Mulund

Essential Job Duties and Responsibilities

Employee is responsible for performing activities in compliance with current established Site procedures of Safety and Quality. Main and additional duties are mentioned below:

- To effectively plan the execution of tasks assigned by completing analyses right-first time and within analytical testing window.

- To perform analyses according to current effective protocol, specifications, analytical methods, and laboratory processes.

- To verify trending of results as per established laboratory procedure.

- To report results and submit the documentation for data validation in a timely manner,

as per established laboratory procedure.

- To immediately escalate to Supervisor issues/ observations suspected to be not in conformity with applicable procedures /policies etc.

- To initiate Quality Issues identified as per applicable procedure, participate in the investigation, perform investigation analysis in timely manner, and provide necessary information to enable implementation of effective CAPA.

- To ensure trainings are completed on time in the electronic learning management system, and all tasks are performed only after completion of trainings on current effective procedures.

- To provide technical/scientific support to other lab personnel within the premise.

- To perform laboratory support activities as per training and perform tasks related to audit readiness.

- Responsible for executing activities in EDMS as per assigned roles and as per applicable procedures.

- To impart training to colleagues.

- To participate in project teams as analytical technical team member, as applicable.

- To attend (in-house) seminars, scientific meetings in own field

- To attend the Department meetings and participate in the initiatives for quality improvement process, as applicable.

- To compile data and collate information, such as required for regulatory submission, or preparation of work instructions and standard operating procedures.

- GMP Responsibility

1. To execute the tasks according to the cGMP guidelines and established laboratory procedures

2. To document execution details contemporaneously and verify completeness of execution record as per established laboratory procedure.

3. To comply with procedure always and ensure lab is in state of audit readiness.

- Quality & Compliance Responsibilities

0. To ensure that respective guidelines on data integrity and laboratory control processes are followed as per established SOPs.

To ensure immediate escalation of issues/observations not in conformity with applicable procedures /policies etc.

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