QA Engineer (QAE)
At a glance
Mid-level QA & Test role at Lupin. Somerset · $70,000–$90,000 base.
techroles summary, based on the employer's posting.
What you'll do
- Keep computerized quality systems running across labs, manufacturing and quality teams, including instruments, PLCs and enterprise applications
- Manage system access, security settings, audit records, backups and reporting for the systems you support
- Support users of Veeva Vault quality and training tools, and improve their workflows, configurations and procedures
- Build quality-system metrics, spot trends and share improvement opportunities with management
- Prepare validation and data-integrity records, review equipment qualifications, and work with technical and business teams to resolve system issues
What you bring
- You have three to eight years in quality systems, computerized-system validation or system administration
- You bring working knowledge of GAMP 5, Annex 11, CSV, data integrity and relevant FDA and EU requirements
- You have supported computerized systems used in laboratory, manufacturing or enterprise settings
Who this fits
This mid-level role suits someone who can handle quality-system administration and validation while working with Quality, IT, Engineering, vendors and business users. The work is generally office-based and may involve lifting up to fifteen pounds occasionally.
From the employer
Shape the Future of Quality Systems and Compliance
Job Description
We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations.
• Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
• Support system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations.
• Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.
• Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.
• Develop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management.
• Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.
• Perform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.
• Support qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment.
• Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.
• Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity.
Qualification and Experience
- Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.
- Experience with Veeva Vault or similar electronic Quality Systems preferred.
- Strong analytical, troubleshooting, communication, and stakeholder-management skills.
- Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred
- 3-8 years of experience in Quality Systems, CSV, systems administration.
- Experience supporting laboratory, manufacturing, and/or enterprise computerized systems
The anticipated salary range for this position in New Jersey is $70,000 .00 to $90,000.00, plus discretionary 7.5% performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails
Competencies
CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility
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