Quality Analyst

Randstad USA; Melville (NY); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Randstad USA in Melville, NY is seeking a Quality Assurance Specialist to support R&D quality oversight, ensuring data integrity and SOP/GMP compliance. The role involves review and approval of quality documents with a focus on specifications.

The position reports to the Director of Global R&D Quality and features a hybrid schedule: on-site Monday-Thursday at 125 Pinelawn Road, Melville, NY, with remote Friday. Contract through 12/4/2026, benefits included.

Qualifications

• Experience in quality oversight for data integrity and SOP/GMP compliance.
• Review and approve quality-related documents with a focus on specifications.
• Ability to maintain quality metrics and support continuous improvement.

Responsibilities

• Maintain Quality Program for R&D functions. 75% involvement in process and document QC.
• Monitor specifications and perform QA checks to ensure data integrity and compliance.

Job description

• Hours: Monday-Friday 9:00-5:00pm with 30 minute unpaid lunch break daily totaling 37.5 hours per week
• Location: Hybrid schedule on-site Monday-Thursday at 125 Pinelawn Road Melville NY, remote Friday
• Contract through 12/4/2026

Job summary:

This position will support R&D and reports to the Director of Global R&D Quality. The position will involve quality oversight for data integrity and compliance with Standard Operating Procedure (SOP), Good Manufacturing Practice (GMP) and applicable regulations. The primary responsibility of the position is review and approval of quality related documents with a focus on specifications.

Responsibilities:

Maintain Quality Program for R&D functions. 75%

• Build collaborative relationships with the groups to understand their processes and quality needs
• Conduct and document QC checks on completed documents according to established SOPs.
• Verify specifications are consistent with source documentation
• Provide corrections and follow-up with technical staff prepare appropriate responses to any identified issues.
• Escalate issues impacting data integrity to management and recommend appropriate actions
• Maintain quality metrics for continuous improvement by quantifying findings identified during document and report QC checks
• Routinely update manager on issues, quality metrics and mitigation efforts by collating issues, tracking trends and making recommendations for remediation

Monitor specifications according to SOPs. 25%

• Establish a prioritization schedule to ensure systematic evaluation of specifications and other related documentation integrity
• Conduct auditing of specifications employing QA checklists to ensure overall compliance and consistency with registration data

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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.