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Clinical Qa Specialist Quality Operations Jobs

Clinical Operations Specialist Jobs
By VSP Ventures At California, United States

Typically Has The Following Skills Or Abilities

Senior Quality Specialist, Gmp Qa Operations
By Agenus At Lexington, MA, United States
Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.
Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.
EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:
Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.
Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production
Qa Operations Manager Jobs
By Novartis At , Indianapolis $107,200 - $160,800 a year
Provide daily leadership and management for the QA Operations Team.
Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
QA and QC experience in pharmaceutical or biotechnology pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Clinical Quality Specialist Jobs
By Talkspace At New York, NY, United States
Assist with clinical risk management
Coordinate with Quality Management about room/documentation audits to guide practitioner action plans
Coordinate with CMO, SVP, Network, Director of Clinical & Quality, and/or Manager of Quality to support execution of special clinical projects
2+ years of clinical experience
Voluntary benefits including disability, basic life or pet insurance, etc.
Flexible PTO and Remote First Environment
Operations Training Specialist - Qa
By Stanford Health Care At , Newark, 94560 $33.45 - $37.68 an hour
Three (3) years of progressively responsible and directly related work experience in a healthcare setting, preferably in a call center environment
Strong written and verbal communication skills, customer service, interpersonal skills and cross-cultural competency.
Knowledge of basic medical terminology
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Expertise of 2 or more specialized functions and primary resource for at least two of the specialized functions
Associate Director, Clinical Qa (Archived)
By GXPeople At ,
BSc/BA, MSc or PhD and a minimum 10 years’ experience in Clinical QA.
Expert knowledge of relevant guidelines and regulations.
Experience working with CROs or other third-parties.
The desire to change / save the world then…
Qa Associate, Quality Operations
By Evotec At , Seattle, Wa
Possess effective task/time management organization skills.
Escalate to QA Operations management of any potential deviations, compliance risks.
Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment preferably in QA Operations.
Prefers candidate with QA Operations experience with On-The-Floor oversight
Excellent verbal and written communication skills.
Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing
Qa Operations Specialist Jobs
By Advanced Accelerator Applications At Millburn, NJ, United States
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
Support FDA/Regulatory interactions for the site activities and products to ensure successful regulatory submissions and inspections.
Specialist Ii, Clinical Operations
By Cerevel Therapeutics At Boston, MA, United States
Assist with the development and implementation of processes and controlled documents in collaboration with Quality Management
Strong computer skills including knowledge of Office365, Microsoft SharePoint, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Outlook, and Microsoft Project
Collaborate/interact with internal and external stakeholders as related to conduct of required job responsibilities
Experience developing meeting agendas and finalizing meeting minutes
Ability to collaborate effectively with the study team, cross-functional team members and external partners (where needed) using collaborative negotiation skills
Experience using Microsoft Office suite products is preferred
Clinical Operations Specialist Jobs
By Assured Allies At Boston, MA, United States
Experience in healthcare/case management systems is a plus
Degree in any of the following fields: occupational therapy, nursing, social work, case management, or related wellness field
Communicate domain knowledge and clinical findings to stakeholders and colleagues
Developing novel program design to address program needs based on clinical experience and data
2+ years of hands-on clinical or wellness experience in a 55+ population
Basic knowledge of research methodologies in controlled and observational settings, including statistics and data analysis methods
Clinical Qa Manager Jobs
By Aurinia Pharmaceuticals Inc. At Rockville, MD, United States
Prepares KPIs for performance monitoring and Management
Minimum 2 years in a supervisory/management role preferred
Functional knowledge of GMP requirements, especially IMP GMP
Manages external auditors for contracted audits (contracts and audit specific activities)
Ensures continued qualifications of GCP related vendors and systemsPrepares and negotiates QA Agreements with vendors, as applicable
Manages study and GCP related Deviations, Quality Issues, CAPA, and Root Cause Analysis
Specialist, Quality Operations Jobs
By BioSpace At Alachua, FL, United States
Experience with using Quality Risk Management principles.
Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.
Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.
Three (3) plus years of related experience in a regulated industry (vaccine, biologics, pharmaceutical)
Two (2) years of quality or GMP experience within a manufacturing organization
Clinical Operations Specialist Jobs
By Cypress HCM At Irvine, CA, United States
Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Good written and verbal communication skills and interpersonal relationship skills
Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
Ability to manage confidential information with discretion
Conduct periodic audits of documentation and may participate in internal master file audits
Clinical Operations Specialist Jobs
By Planet Pharma At United States
Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
Top three non-negotiable technical skills and years of experience required for candidate.
High level of detail oriented, lots of data entry and templates
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Good written and verbal communication skills and interpersonal relationship skills
Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
Clinical Quality Operations Manager
By Merck At Rahway, NJ, United States
Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.
Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Experience with delivering effective CAPA management solutions.
Experience with risk management tools and processes within the clinical quality framework.
Excellent project management and organizational skills.
Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.
Clinical Quality Specialist - Wfh
By Sarah Cannon At United States
Prepares for and hosts external sponsor / IRB audits
Investigates and responds to Corrective and Preventive Action (CAPA) requests in collaboration with Clinical Operations and CQA.
Works with Clinical Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.
Reviews monitor letters for issue escalation and quality performance issues
Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.
Coordinates and facilitates quality review meetings with appropriate CQA staff and operational leadership
Sr Qa Operations Specialist
By Novartis At , Indianapolis, In $88,000 - $132,000 a year
Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
Review, approve and support investigations, corrective and preventive actions, change controls, and complaints, as required.
Quality Operations Specialist Jobs
By Seagen At , Bothell, 98021, Wa $98,000 - $127,000 a year
Ensure label requirements for each country are defined
8 years professional work experience in regulated industry with Bachelor's degree, or 10 years' experience with Associate’s degree
8 years professional experience in Quality role in pharmaceutical or biotech company
Ensure overall compliance of Clinical and Commercial products for all regions
Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls
Support product launch activities for introduction of product into new countries
Qa Operations Manager Jobs
By Novartis At , Indianapolis, In $107,200 - $160,800 a year
Provide daily leadership and management for the QA Operations Team.
Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
QA and QC experience in pharmaceutical or biotechnology pharmaceutical industry with environmental monitoring & cleanliness zones
Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
Assist functional areas with achieving timely and compliant final product disposition of the product.
Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
Director, Clinical Development & Quality Operations
By Azurity Pharmaceuticals At Woburn, MA, United States
Identify and escalate significant compliance issues to Azurity R&D Senior Management including assessment of serious breaches.
Develop training materials and conduct training to ensure compliance with applicable regulatory and GCP requirements.
Experience preparing and presenting to Executive and Senior Leadership to gain alignment on proposed action and direction for potential drug products.
Experience and/or Training: Minimum of 10 years of pharmaceutical industry experience; minimum of 5 years of clinical experience preferred.
Sound understanding of US and ex-US Regulatory clinical requirements.
Strong communication skills (both written and verbal) with an ability to express complex information clearly and concisely.

Are you looking for an exciting opportunity to join a dynamic team and make a difference in the quality of healthcare? We are looking for a Clinical QA Specialist to join our Quality Operations team and help ensure the highest standards of patient care. As a Clinical QA Specialist, you will be responsible for monitoring and evaluating clinical processes, identifying areas of improvement, and developing and implementing corrective action plans. If you are passionate about quality and have a strong attention to detail, this could be the perfect job for you!

Overview:

Clinical QA Specialist Quality Operations is responsible for ensuring the quality of clinical operations and processes. They are responsible for developing, implementing, and maintaining quality assurance systems and processes to ensure compliance with applicable regulations and standards. They are also responsible for conducting audits, analyzing data, and providing feedback to ensure that processes are effective and compliant.

Detailed Job Description:

Clinical QA Specialist Quality Operations is responsible for developing, implementing, and maintaining quality assurance systems and processes to ensure compliance with applicable regulations and standards. They are responsible for conducting audits, analyzing data, and providing feedback to ensure that processes are effective and compliant. They are also responsible for developing and maintaining quality metrics, tracking and reporting on quality performance, and identifying and resolving quality issues. Additionally, they are responsible for providing guidance and training to clinical staff on quality assurance processes and procedures.

What is Clinical Qa Specialist Quality Operations Job Skills Required?

• Knowledge of applicable regulations and standards
• Knowledge of quality assurance systems and processes
• Excellent analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to manage multiple tasks and prioritize work
• Ability to work in a fast-paced environment

What is Clinical Qa Specialist Quality Operations Job Qualifications?

• Bachelor’s degree in a related field
• At least 3 years of experience in a quality assurance role
• Knowledge of applicable regulations and standards
• Knowledge of quality assurance systems and processes
• Excellent analytical and problem-solving skills
• Excellent communication and interpersonal skills

What is Clinical Qa Specialist Quality Operations Job Knowledge?

• Knowledge of applicable regulations and standards
• Knowledge of quality assurance systems and processes
• Knowledge of data analysis techniques
• Knowledge of quality metrics and reporting
• Knowledge of process improvement techniques

What is Clinical Qa Specialist Quality Operations Job Experience?

• At least 3 years of experience in a quality assurance role
• Experience in developing and implementing quality assurance systems and processes
• Experience in conducting audits and analyzing data
• Experience in providing guidance and training to clinical staff
• Experience in identifying and resolving quality issues

What is Clinical Qa Specialist Quality Operations Job Responsibilities?

• Develop, implement, and maintain quality assurance systems and processes
• Conduct audits and analyze data to ensure processes are effective and compliant
• Develop and maintain quality metrics, track and report on quality performance
• Identify and resolve quality issues
• Provide guidance and training to clinical staff on quality assurance processes and procedures
• Monitor and report on quality performance