| Company: | JOHNSON&JOHNSON |
|---|---|
| Job Role: | QA Validation Associate II |
| Experience: | (2+years): |
| Vacancy: | 10+ |
| Qualification: | Bachelor Degree in Engineering/Science/ or Related Field |
| Salary: | Upto $75,000USD/PA |
| Location: | Malvern USA |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
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- Review and approve system discrepancies, exceptional conditions and non-conformances that may occur during execution of initial validations, re-qualifications, and re-validations and execute in HPLM.
- Provide quality input on a variety of compliance related issues and attend meetings as a quality representative.
- Partner with QA Document Control, QC, Manufacturing, Execution Systems, Plant Logistics, Validation/Compliance, and Regulatory Affairs to ensure documentation/process changes align with regulatory filings and maintain validated process.
- Increase the compliance profile by identifying gaps within processes and procedures. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
- Provide support on Local and Global Change controls-related items such as providing input on the proposed changes impact assessments and implementation plans.
- Revise and acquire approval for departmental documents and coordinate document approvals against timelines.
- Support internal and external audits, inspections, FDA pre-inspection readiness, certifications, tracking, and trending activities.
- Support the maintenance program by reviewing, approving, and documenting within SAP or EFMS the Work Requests, Work Orders, PM/Calibration Extensions, and PM/Calibration Change Requests.
- Independently perform QA Compliance Validation activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.
- Work independently on routine tasks and will have support to resolve some complex technical issues.
Education:
- Bachelor’s Degree required; focused degree preferred in Engineering, Science, or equivalent technical subject area
- Required:
- Minimum 2 years of relevant work experience
- Direct QA Validation and validation services experience within a GxP regulated manufacturing environment
- Proficient technical writing skills, including strong organizational, communication, and project management skills
- Preferred:
- Biotechnology or pharmaceutical industry experience
- GMP Manufacturing equipment and/or automation validation experience
- Manufacturing execution software experience
- Quality investigations experience
- Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
- At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey,
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