Job Description
Job DescriptionData Reviewer
WATERS EMPOWER EXPERIENCE REQUIRED
Location: Near Miami and Fort Lauderdale, FL
Function: R&D / Pharmaceutical Product Development
Reports To: Senior Director, Analytical Sciences
Employment Type: Contract-to-Permanent
Compensation: $35–$40 per hour, depending on experience and qualifications
Position Overview
We are seeking a Data Reviewer with hands-on experience using Waters Empower chromatography data software to support pharmaceutical product development activities within a regulated R&D environment.
Candidates MUST have previous experience working with Waters Empower, reviewing chromatographic data, and verifying analytical results in a pharmaceutical or cGMP-regulated environment. Direct experience working for a pharmaceutical or biotechnology company is also required.
This role is primarily responsible for technical data review, chromatographic data verification, documentation review, and data integrity activities prior to submission of R&D records to Quality Assurance (QA) for review and release.
The ideal candidate will have at least three years of experience in a cGMP-regulated pharmaceutical, analytical, laboratory, QC, or R&D environment, with strong attention to detail and a solid understanding of laboratory documentation and data integrity requirements.
Key Responsibilities1. Data Review & Data Integrity
- Conduct technical reviews of R&D laboratory data and supporting documentation.
- Review chromatographic data using Waters Empower software.
- Verify analytical results, chromatograms, integrations, calculations, and supporting documentation for accuracy, completeness, consistency, and integrity.
- Review laboratory records and analytical results for compliance with applicable procedures.
- Identify discrepancies, missing information, documentation issues, and potential data integrity concerns.
- Work with laboratory and R&D personnel to resolve documentation and data-related issues.
- Ensure R&D records meet applicable technical and quality requirements before QA review and release.
2. Documentation & Reporting
- Organize, maintain, and control documentation and records associated with R&D product development activities.
- Review technical documents and laboratory records for completeness and accuracy.
- Draft summary reports based on laboratory and R&D data.
- Prepare charts, tables, graphs, and other visual representations of scientific data.
- Maintain appropriate documentation in accordance with SOPs and applicable quality requirements.
- Upload and maintain R&D documents within electronic document management systems (EDMS).
- Ensure documentation is properly organized, traceable, and readily accessible.
3. Project & Team Support
- Coordinate routine project activities, documentation, materials, and communications with internal teams and external partners.
- Participate in project and team meetings and maintain accurate meeting records.
- Track assigned action items and follow up to ensure timely completion.
- Support project timelines and contribute proactively to team objectives.
- Work collaboratively with R&D, analytical laboratory, QA, and other cross-functional teams.
4. Compliance & Quality
- Perform all activities in accordance with applicable SOPs, quality standards, and company procedures.
- Maintain a strong focus on data integrity, documentation accuracy, and compliance.
- Support a culture of quality and continuous improvement within the R&D organization.
- Follow applicable cGMP requirements and laboratory documentation practices.
Required Qualifications
- Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, Forensic Science, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 3+ years of experience in a cGMP-regulated pharmaceutical, analytical, laboratory, QC, or R&D environment.
- Hands-on experience with Waters Empower chromatography data software is REQUIRED.
- Previous experience reviewing chromatographic data, chromatograms, integrations, analytical results, and calculations using Empower is REQUIRED.
- Previous direct employment experience with a pharmaceutical, biotechnology, or life sciences company is REQUIRED.
- Experience working within established pharmaceutical quality systems, SOPs, and documentation practices.
- Familiarity with analytical laboratory methodologies and instrumentation, including:
- HPLC / UPLC
- UV-Vis
- GC
- Other common analytical laboratory equipment.
- Strong understanding of laboratory documentation, analytical data review, and data integrity practices.
- Ability to identify discrepancies and inconsistencies in scientific data and documentation.
- Proficiency in Microsoft Excel, Word, and PowerPoint.
- Strong organizational, written, and verbal communication skills.
- Ability to work independently and collaboratively in a cross-functional environment.
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