GMP Data Integrity QA Specialist - FDA Readiness
United Pharma
United Pharma is seeking experienced QC Specialists to support a GMP pharmaceutical site undergoing FDA improvement initiatives. This role focuses on retrospective laboratory record review, documentation compliance, data integrity, and inspection readiness. Responsibilities include reviewing historical lab equipment logbooks, evaluating data for duplicate test preparations, identifying gaps, and supporting deviations and investigations as needed to withstand regulatory scrutiny. #J-18808-Ljbffr United Pharma
$145.2k - $217.88k
DescriptionThe Scientific Computing and Data team at the Icahn School of... ...scientific discovery. The AI-Ready.Mount Sinai (AIR.MS) platform... ...Data Warehouse. AIR.MS is integrated with Minerva, a high-... ...Engineer is a senior technical specialist responsible for leading the ongoing...SuggestedTraineeshipLocal area$40 - $45 per hour
A well-known biopharmaceutical company is seeking a remote QA Specialist for a short-term contract. This role involves leading deviation investigations and writing CAPAs, requiring 4 to 7 years of GMP quality assurance experience. Candidates should have hands-on experience...SuggestedRemote jobHourly payTemporary work- This role sits at the intersection of Data Management & Governance, enterprise data quality assurance, Responsible AI operations, data... ...mature a control plane that provides visibility into AI data readiness, data quality health, control coverage, exceptions, incidents,...Suggested
- ...coupling comprehensive clinical data with donor samples. As the... ...Quality Assurance Principal Specialist serves as a senior Quality... ...of audit and inspection readiness, and ensuring the effectiveness... ...# Ensure compliance with GMP, GLP, GDP, FDA, EMA, ISO, USP, USDA, and other...SuggestedTemporary workWork at office
- Kraken is seeking a Data Architect within the Data & Audit Readiness team to own inventories, catalogs, and access processes ensuring audit readiness across datasets and systems. You will build ETL pipelines and audit‑ready data architecture, collaborating with Risk, IT...Suggested
$62.36k - $128.7k
...diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced... ...programs and associated data trends. Provide oversight... ...expectations and inspection readiness activities. Strong technical... ...into medicine has led to nine FDA-approved treatments and...Work experience placementMonday to Friday- We are seeking experienced QC Specialists to support a GMP pharmaceutical manufacturing site undergoing an active FDA improvement initiative. This role will focus... ...review, documentation compliance, data integrity, and inspection readiness. Key Responsibilities: Review...
$110k - $150k
...their team in New York City. The role focuses on ensuring compliance with regulatory reporting requirements and involves performing data validation, conducting Quality Assurance Reviews, and maintaining issue logs. The ideal candidate holds a Bachelor's in Accounting and...- ...Pharma is looking for a Quality Management Specialist in New Jersey to support batch record... ...ideal candidate will have over 5 years of QA/QC experience and a strong background in batch... ...investigations, and ensuring compliance with GMP regulations. A Bachelor's degree in...
$145.2k - $217.88k
Mount Sinai Medical Center is seeking a Lead Data Warehouse Engineer to integrate multi-modal clinical data into the AIR.MS data warehouse. This senior role involves designing data pipelines, mentoring engineers, and ensuring compliance with privacy regulations. Candidates...- ...exceptional service. We're looking for a Complaints & Quality Assurance Specialist to join our Customer Experience team.This is a unique hybrid... ...Saturdays and Sundays, forms part of the core working schedule.Ready to help shape exceptional member experiences while driving...Permanent employmentFull timeWork at officeLocal areaWorldwideWeekend work
- Percepta is hiring one of the founding members of its data team, a role that spans data engineering, data science and ML engineering.... ...data packs, and ontology that turn messy enterprise data into AI-ready assets, and creating tooling to make data work faster and...
- Northeastern University is seeking a Snowflake Developer to design, optimize, and operationalize a modern Snowflake data platform and AI-ready data products. You will work across legacy systems to build scalable pipelines and ensure governance, security, and performance...3 days per week
$72k
...invoices. The role assists QA product managers with... ...with Acrotech SOPs. The Specialist will also help ensure that... ...documentation and data for annual product reviews... ...Review status updates to FDA. Perform additional duties... ...of experience in a GMP environment such as a pharmaceutical...Temporary workFor contractorsWork at officeFlexible hours$104.29k - $141.09k
...while transforming your career. Specialist Quality Assurance Location... ...Good Manufacturing Practices (GMP), Good Distribution Practices... ...to ensure operational success Integrate risk management strategies into... ...Technologies Prior experience overseeing QA in distribution, warehousing,...Flexible hours$66.7k - $87.12k
...Assurance and Quality Control (QA/QC) Specialist serves as part of the Second... ..., complete, and audit-ready Track and monitor the status... ...relationships Experience with data analysis tools, reporting tools... ...fit: Our Core Values are an integral part of who we are and who we...Local areaFlexible hours$66.3k - $75k
...: The Quality Assurance (QA) Specialist at Fedcap Inc is responsible for ensuring the integrity and continuous improvement of... ...maintaining 100% accuracy in reported data. Work collaboratively with... ...include case management, work readiness, vocational and employer based...Ongoing contractContract work- ...and best practices. Quality Assurance Specialist This role reviews auditor work... ...flagged or high‑risk audits to ensure integrity and consistency across the audit team.... ...audit accuracy, review turnaround, auditor readiness) to leadership. Maintain digital records...Part timeRemote workFlexible hours
- .... This role sits at the intersection of Data Management & Governance, enterprise data... ...plane that provides visibility into AI data readiness, data quality health, control coverage,... ...recertification, and closure evidence. Integrate data quality controls into AI lifecycle...Long term contract
- ...full lifecycle, ensure availability, design schemas, and implement security controls in a high‑availability environment. You will integrate databases with DevSecOps pipelines (Kubernetes, Jira, Bitbucket, Confluence) and collaborate with developers, cybersecurity, and systems...Remote job
- BairesDev is looking for a Data Entry professional to accurately input, update, and maintain data across various systems. You will ensure data integrity and support business operations with meticulous attention to detail. The ideal candidate has over 3 years of experience...Remote jobWork at officeFlexible hours
- Feedinkoo is searching for a results-oriented Provider Relations Credentialing Specialist to join our elite team. This role involves providing essential administrative support to the provider management team and ensuring the timely processing of roster updates. The ideal...
- Feedinkoo is seeking a Remote Data Entry Specialist responsible for accurately inputting and maintaining information in digital databases. This entry-level role requires attention to detail, reliability, and the ability to work independently. Ideal candidates will have...Remote jobFlexible hours
- MaziCTools in the United States is looking for a Data Entry Operator who will be responsible for accurately entering and managing data in our systems. You will ensure timely data entry and maintain high accuracy, supporting HR and various departments in smooth operations...
- ...an entry-level Regulatory Affairs & Quality Assurance Associate in Brooklyn, NY to support FDA 510(k) submissions, NIOSH approvals, and QMS management. You will report to the RA/QA leadership and learn the complexities of FDA, NIOSH, and ISO standards while growing into...
- QA Specialist — Deviation Writing and CAPA | Remote | Contract A well-known biopharmaceutical company... ...investigations including initial data review, gap identification, root cause analysis... ...event Qualifications 4 to 7 years of GMP quality assurance experience — biopharma...Contract workTemporary workRemote workShift work
- .... Summary The Senior Quality Assurance (QA) Specialist is responsible for the review of various... ...and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc..) for the site. Conduct... ...completion of assigned tasks. Lead and drive the GMP activities, work with manufacturing...Contract work
- QA & Verifications Specialist Are you a skilled QA & Verification Specialist ready for a challenging and rewarding next step? Do you combine strong technical expertise with... ...primary focus of this role is to ensure the integrity and reliability of our customers’ software...Work at officeRemote work
- Amgen’s Easton, PA site seeks a Specialist Quality Assurance to provide critical QA support for the Raw Material Center (RMC). The role focuses on incoming materials, GMP/GDP compliance, and collaboration with manufacturing and logistics to ensure quality across receipt...
- An IT consulting firm is seeking an experienced SQL DBA Consultant to provide hands-on database administration and optimization. This mid-senior level position requires strong SQL Server DBA skills, the ability to thrive in client-facing roles, and proactive problem-solving...Contract work
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