senior quality assurance specialist

Language Matters

Our client is searching for a Spanish speaking Quality Assurance Specialist with expertise in regulations, fraud detection and investigative techniques. If you're passionate about Quality Assurance, screening processes and investigations, driving operational excellence and leading from the front then this is the role for you. The role is due to start in January 2026 and is fully remote anywhere in the UK.Please note, the client will not offer visa sponsorship for the role.Key responsibilities:<ul> <li>Analyse and understand customer communications and review business accounts for potential trends and ongoing risks</li><li>Supporting other team members with QA investigative reports for further screening</li><li>Conduct investigations to identify potential fraud, money laundering, finance breaches, corruption and tax evasion</li><li>Collaborate with stakeholders to refine strategies and provide guidance to mitigate risks</li></ul> About you:We are looking for a fluent Spanish and English speaker with previous experience in fraud investigations, risk prevention and quality assurance, to be part of a high-performing, international team. Person specification:<ul> <li>Fluent Spanish and English</li><li>Strong fraud investigations, risk prevention, quality assurance or risk analyses experience within a regulated environment</li><li>Proven ability to handle complex investigation or screening processes</li><li>Knowledge of the latest insights in to Financial Crime across the UK and EU is highly advantageous</li></ul> To apply, please send your CV in English and in Word format to Frank. languagematters is acting as an employment agency in relation to this vacancy.

Spanish speaking Quality Assurance Specialist UK-based

Tadbeer Recruitment Company

Quality Assurance Specialist

EVA Pharma

<div>Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. 
Job Summary 
We are seeking a passionate and talented Quality Assurance Specialist to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry. 
 
Responsibilities:
<ul><li>Monitor environmental conditions (temperature, humidity, pressure differentials) and ensure they comply with GMP requirements across production and warehouse areas</li>
<li>Participate in raw material dispensing and verify specifications and calculations as per SOPs</li>
</ul><ul><li>Oversee manufacturing and packaging operations to ensure adherence to GMP, SOPs, and data integrity requirements</li>
<li>Review batch records and logbooks for completeness, accuracy, and compliance with GDP (Good Documentation Practice)</li>
<li>Record and report deviations, non-conformities, and incidents. Participate in root cause investigations and track corrective and preventive actions (CAPA)</li>
</ul>
Requirements<ul><li>
Bachelor's degree in Pharmacy.</li><li>
0-2 years of relevant experience in a pharmaceutical QA environment</li><li>
Knowledge of cGMP and GDP principles</li><li>
Understanding of CAPA, change control, and quality documentation systems</li><li>
Familiarity with ISO 9001 and safety programs</li><li>
Awareness of validation principles and basic statistical concepts</li></ul></div>

Advanced Group

<div>Overview 
We are seeking a detail-oriented and proactive Quality Management Specialist to support Good Clinical Practice (GCP) quality oversight across multiple clinical studies. This role will partner closely with cross-functional teams, Quality leadership, and external vendors to ensure compliance, support audits, contribute to inspection readiness, and assist in the development and review of controlled documents. The ideal candidate will have a strong interest in clinical quality, solid foundational GCP knowledge, and the ability to collaborate effectively across teams.
Key Responsibilities 
Study Quality Oversight
<ul><li>Shadow 3 ongoing studies and support 7 additional studies from planning through reporting to provide Quality oversight and recommend best practices.
</li><li>Communicate and collaborate with cross-functional stakeholders, including Clinical Management and Functional Areas, regularly attending study and project-level meetings.
</li></ul>Quality Issue Management
<ul><li>With guidance from Senior GCP Level 1 team members, support evaluation of critical quality issues, potential Serious Breaches, significant noncompliance, data integrity concerns, and protocol deviations.
</li><li>Escalate issues to Senior Management and conduct periodic follow-up on resolution activities for assigned studies.
</li></ul>Audit &amp; Risk Assessment Support
<ul><li>Contribute to annual GQM audit planning by supporting risk assessments and recommending the number of site and vendor audits based on study risk.
</li><li>Provide study-level information and documentation to GCP Level 2 and audit teams in preparation for audits.
</li><li>Participate in vendor risk assessments to inform the annual Vendor Audit Plan.
</li></ul>CAPA, Documentation, &amp; Quality Governance
<ul><li>Assist in reviewing Corrective and Preventive Actions (CAPAs) related to audits, inspections, quality issues, and eTMF findings.
</li><li>Participate in weekly, monthly, and quarterly GQM/GCP governance meetings.
</li><li>Attend QA-to-QA and Quality Council meetings with CRO partners alongside a Senior GCP team member.
</li><li>Contribute to the review and harmonization of controlled documents (protocols, ICFs, CSRs, amendments, SOPs, templates, etc.).
</li></ul>Training &amp; Inspection Readiness
<ul><li>Receive formal GCP training on ICH E6(R3), 21 CFR&ndash;related modules, and additional quality materials.
</li><li>Participate in weekly team training and support meetings.
</li><li>Support inspection readiness activities across Sponsor, Site, and CRO functions, including delivering &ldquo;Do &amp; Don&rsquo;t&rdquo; training, participating in interview prep/debriefs, and reviewing outputs from Inspection Readiness and Pre-Inspection visits.
</li></ul>Pharmacovigilance Support
<ul><li>Review and assess the Pharmacovigilance System Master File (PSMF).
</li><li>Assist with PV-related quality activities as assigned.
</li></ul>Qualifications
<ul><li>Bachelor&rsquo;s degree required.
</li><li>Pharmaceutical, biotech, or clinical research background preferred.
</li><li>Foundational knowledge of GCP and ICH E6 guidelines strongly preferred.
</li><li>Strong communication, organization, and collaboration skills with the ability to support multiple projects simultaneously.
</li><li>Detail-oriented with an interest in quality assurance and compliance.</li></ul> 
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.</div>

Quality Management Specialist II (2649-1)

Business Leaders

<div>
 
 
 Senior QA Chemist &ndash; Medical
 
 
 
 
 
 
 Business Leaders is hiring on behalf of one of our clients, a leading medical devices manufacturer in
 
 Badr City
 
 (transportation allowance provided)
 
 
 
 
 
 
 Job Summary:
 
 
 
 The Senior QA Chemist will oversee QA documentation, in-process control (IPC) activities within production and ensure full compliance with quality standards and documentation systems. The role also includes leading audit preparation and ensuring readiness for GMP, ISO, and other regulatory audits.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Conduct and supervise IPC testing during production stages.
 </li>
 <li>
 Review and maintain all quality documentation, SOPs, and batch records.
 </li>
 <li>
 Support preparing technical files for products registration
 </li>
 <li>
 Support internal and external audits and ensure corrective/preventive actions are implemented.
 </li>
 <li>
 Ensure compliance with GMP and regulatory standards.
 </li>
 <li>
 Collaborate with production, QC, and regulatory teams to uphold product quality.
 </li>
 </ul>
 
 
 
 
 
 Requirements:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Chemistry, Science, or related field.
 </li>
 <li>
 Minimum 4&ndash;6 years of experience in Quality Assurance, preferably within medical device, or pharmaceutical manufacturing.
 </li>
 <li>
 Strong understanding of QA documentation, validation, and quality systems.
 </li>
 <li>
 Ability to commute to Badr City (transportation allowance provided).
 </li>
 </ul>
 
 
 
 
 
 Interested candidates
 
 are invited to apply here or send their updated CVs
 
 to bleaders.eg@gmail.com
 
 mentioning
 
 &ldquo;
 
 
 
 Senior QA Chemist
 
 
 
 &rdquo;
 
 in the subject line.
 
</div>

Senior Quality Assurance Chemist – Medical

Curium Pharma

<div>
 
 
 ABOUT CURIUM
 
 
 
 
 
 
 The Group Curium is the world&rsquo;s largest nuclear medicine company with over 1 b &euro; revenues. At Curium, we have a singular focus &ndash; to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 15 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.
 
 
 Building on its unique strengths across radiopharmaceutical product manufacturing, logistics and commercialization, and led by an agile, LBO-driven leadership team, Curium has already achieved a critical mass and is the largest player in the nuclear medicines field. This is one that has become increasingly dynamic and innovative in recent years, in particular following Novartis&rsquo; acquisitions of Advanced Accelerator Applications and Endocyte.
 
 
 
 
 
 
 Position Summary
 
 
 
 
 
 
 At CURIUM Pharma, we are looking for a Pharmacovigilance (PV) Quality &amp; Compliance Specialist to ensure the full compliance of our global and local pharmacovigilance systems with quality standards and regulatory requirements.
 
 
 In this role, reporting directly to the Compliance PV Manager, you will play an active role in critical processes such as SDEA management, audit/inspection preparation, CAPA tracking, and the analysis of quality indicators (KPIs).
 
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 1. Quality Assurance &amp; Monitoring
 
 <ul>
 <li>
 Perform reconciliations with PV partners, the quality complaints database, and digital channels.
 </li>
 <li>
 Prepare KPIs (Key Performance Indicators) for all pharmacovigilance activities, report trends, and propose corrective actions for performance improvements.
 </li>
 <li>
 Initiate and manage CAPA, Deviation, and Change Control processes in the QA database, ensuring timely follow-up and closure.
 </li>
 <li>
 Prepare source data to maintain the CURIUM Pharmacovigilance System Master File (PSMF) and its annexes (specifically Annex B, C, and F).
 </li>
 </ul>
 
 2. Contract &amp; Partner Management (SDEA)
 
 <ul>
 <li>
 Create, update, and maintain Safety Data Exchange Agreements (SDEAs) for all CURIUM partners.
 </li>
 <li>
 Send and assess compliance questionnaires for new and existing partners; verify the implementation of obligations such as SOP dissemination and training.
 </li>
 <li>
 Supervise CROs and partners to ensure compliance with regulatory deadlines for Adverse Event (AE) reporting.
 </li>
 </ul>
 
 3. Audits &amp; Inspections
 
 <ul>
 <li>
 Contribute to the preparation of the yearly PV audit plan.
 </li>
 <li>
 Coordinate and prepare the PV department for internal and external audits and inspections, ensuring readiness for Agency expectations.
 </li>
 <li>
 Monitor the follow-up of CAPAs resulting from audits/inspections and verify their effectiveness.
 </li>
 </ul>
 
 4. Training &amp; Documentation
 
 <ul>
 <li>
 Implement and control the application of PV procedures (SOPs) in the eDMS.
 </li>
 <li>
 Review and update PV training materials and track employee training status via the LMS (Learning Management System).
 </li>
 <li>
 Manage the long-term archiving of pharmacovigilance documents related to local activities.
 </li>
 </ul>
 
 
 
 
 
 Requirements
 
 
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree in Pharmacy, Biology, Chemistry, or related Life Sciences.
 </li>
 <li>
 Experience: Minimum 2-4 years of experience in the Pharmaceutical industry, specifically in Pharmacovigilance or Quality Assurance (QA).
 </li>
 <li>
 Regulatory Knowledge: Strong knowledge of Good Pharmacovigilance Practices (GVP) and local/international regulations.
 </li>
 <li>
 Technical Skills: Practical experience in managing SDEAs, updating PSMF, and handling Audit/CAPA processes is highly preferred.
 </li>
 <li>
 Language: Fluent in English (Written and Spoken) is mandatory for global communication and documentation.
 </li>
 <li>
 IT Skills: Proficient in MS Office; experience with safety databases, eDMS, and LMS systems is an asset.
 </li>
 <li>
 Competencies: Strong analytical thinking, attention to detail, excellent planning/organizational skills, and a proactive team player.
 </li>
 </ul>
 
 
 
 
 
 
 Disclaimer
 
 
 
 
 
 
 The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
 
 
 
</div>

Pharmacovigilance Quality Assurance Specialist

LabConnect, LLC

Overview
 
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
 
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
 
The Quality Specialist, Sr. is responsible for assisting Quality Leadership with ensuring compliance, optimizing quality processes, and implanting strategic enhancements of the Quality Management System (QMS) in support of clinical trial operational activities. The Quality Specialist, Sr. will serve as administrator for the quality management software (QMS) and is responsible for development, configuration, and management of the QMS.
 Please note: this is a hybrid role and requires 2-3 days per week of onsite presence at our office in Johnson City, TN.
 
Essential Duties and Responsibilities: 
<ul>
<li>Leads and project manages QMS activities, ensuring robust implementation and continuous improvement of document control, change control, non-conformance reporting, and supplier qualification/requalification processes within the QMS framework.</li>
<li>Serves as team lead, in a non-supervisory capacity, on QMS-related systems, ensuring compliance with regulatory standards</li>
<li>Responsible for QMS metrics and reporting to leaders across the company</li>
<li>Supervise and assist in management of QMS Quality Event reporting and related investigation, root cause analysis, proposed corrective and/or preventive measures, and timely closure</li>
<li>Trains QMS users on workflow and associated tasks for modules within the QMS</li>
<li>Leads configuration, optimization, and continuous improvement initiatives for electronic QMS (eQMS), ensuring alignment with organizational quality objectives and regulatory requirements</li>
<li>Identifies and drives QMS-centric Lean and process efficiency initiatives, leveraging data analytics and stakeholder input to enhance system performance and user experience</li>
<li>Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses</li>
<li>Provide expert-level QMS compliance guidance and strategic quality assurance consultation to internal teams and external partners, ensuring adherence to industry best practices and regulatory expectations.</li>
<li>Schedules and conducts monthly quality review meetings as required.</li>
<li>Prepare training materials and conduct training for QMS topics.</li>
<li>Collaborates with Human Resources regarding training program requirements affected by the QMS.</li>
<li>Serves as Quality subject matter expert for configurable systems validation projects.</li>
<li>Conducts research and compiles reports.</li>
<li>Performs other tasks as defined by the Quality Assurance Leadership</li>
</ul>
Education and Experience: 
<ul>
<li>2-year Associate degree with 8-10 years related experience and/or training required, or</li>
<li>4 -year bachelor’s degree preferred with 5-7 years of Quality Assurance Experience</li>
</ul>
Skills and Abilities: 
<ul>
<li>Must possess strong organizational and interpersonal skills.</li>
<li>Experience with QMS platforms such as Veeva is highly preferred.</li>
<li>Proven track record of leading QMS implementations or enhancements is a strong asset.</li>
</ul>
Supervisory Responsibilities: None
 
Physical Demands: 
While performing the duties of this job, the occupant is regularly required to:
 <ul>
<li>Prolonged periods of sitting at a desk and working on a computer.</li>
<li>Prolonged use of computer and headphones for conference calls.</li>
<li>Communicate effectively via phone, video, and email.</li>
<li>Use hands and fingers to operate a computer and other office equipment.</li>
</ul>
Travel Requirements: Minimal
 
Join our team and discover how your work can impact patients' lives around the world!
 
Some of the Perks our LabConnectors Love: 
<ul>
<li>Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)</li>
<li>Health Benefits beginning on date of hire</li>
<li>PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community</li>
<li>Short and Long-Term Disability, Life Insurance, and AD&D</li>
<li>We celebrate our differences, which enriches our culture!</li>
</ul>
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
 We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters
 LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
 If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.

Senior Quality Specialist

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10000 senior quality assurance specialist jobs NEAR_ME

Spanish speaking Quality Assurance Specialist UK-based

Quality Assurance Specialist

Quality Assurance Specialist

Quality Management Specialist II (2649-1)

Senior Quality Assurance Chemist – Medical

Pharmacovigilance Quality Assurance Specialist

Senior Quality Specialist