Register
Recruit Create CV

Csv Qa Specialist Jobs

Specialist, Qa Disposition Jobs
By Bristol Myers Squibb At , Township Of Warren
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Equivalent combination of education and experience acceptable.
Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Qa Specialist Jobs
By ARC-One Solutions At , Miramar, 33023, Fl
Organizes documents for management review, software release, and audits
Provides support to the supplier management process
Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution
Experience in external inspections by regulatory bodies
Skill in Microsoft Office applications.
Creates and monitors reports for departmental key performance indicators, tracks and trends
Senior Qa Specialist Jobs
By Neuralink At , Fremont, Ca $95,026 - $124,200 a year
Performs ongoing compliance audits using standard evaluation tools for audit/monitoring activities and ensures adherence to regulatory requirements.
Assists with monitoring activities involving the effective execution of corrective action requirements.
4+ years of experience in clinical quality assurance or related roles.
Proficient in Good Clinical Practice (GCP) guidelines and regulatory requirements.
Strong quality assurance and analytical skills.
Excellent communication and collaboration abilities.
Qa Specialist I Jobs
By uniQure At , Lexington, 02421, Ma
Support the continuous improvement and oversight of Quality Management System procedures.
1-3 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Experience working in a GMP manufacturing environment
Ability to manage multiple activities with challenging timelines
Review and approve batch records and solution lot records.
Support internal and external audits.
Qa Specialist Ii Jobs
By GSK At , Cambridge, 02142, Ma
Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
Demonstrated experience in regulatory inspection activities.
Experience working successfully both independently and in a team environment.
Strong verbal and written communication skills.
Root cause analysis experience preferred.
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.
Csv Consultant Jobs
By Stellar Consulting Solutions, LLC At Kankakee, IL, United States
Experience with Alan Bradley systems such as Rockwell Automation Factory Talk, MES, PLC, SCADA. SIEMENS
Experience with Periodic CSV Review
Experience with manufacturing GMP Automation systems
No IT resource but someone who has worked in manufacturing site preferably from manufacturing background.
Periodic review of about 35 Automation systems and can be extended further to 200 odd systems.
Once onboarded will need to plan for periodic review of all the systems in scope and then start periodic review.
Csv/Di Consultant Jobs
By Compliance Group Inc At United States
Authoring and executing technical commissioning and qualification documentation
System requirements and description (URS)
Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.
Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
QA CSV/ CSA senior level resource that has experience
Csv Data Integrity Specialist
By LS Solutions At United States
CSV/DI Consultant that has experience with Data Integrity
Authoring and executing technical commissioning and qualification documentation
System requirements and description (URS)
Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.
Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
Qa Specialist Jobs
By Aspen Medical At El Paso Metropolitan Area, United States
Quality improvement experience and knowledge of QI processes such as PDSA, FMEA, and root cause analysis.
Bachelor's degree in Human Services, Healthcare Management, or a related field or
Basic Life Support (BLS) certification.
Setting strategic priorities for quality assessment and improvement.
Assisting with the development, review, and analysis of all elements of the QI program.
Associate or Bachelor's degree in Nursing from an approved, accredited school of nursing.
Qa Specialist Jobs
By Saipro Systems At Richmond, VA, United States
Skill Required / DesiredAmount of Experience
*Hybrid work schedule preferred; 100% remote will be considered for highly qualified candidates.
interview:web cam or in person
*Develop and implement automated testing scripts
*Assist with system security scans
*Assist with implementation of Agile development methodology and aid with QA team adoption
Csv Engineer Jobs
By Thrustex At Chicago, IL, United States
·System Validation Planning: Develop validation strategies and plans for our software platform, considering regulatory requirements and industry standards.
User Requirement Specification (URS): Collaborate with stakeholders to gather and document user requirements, ensuring they are accurately translated into functional specifications.
Functional Requirement Specification (FRS): Translate user requirements into detailed functional specifications that guide the design and development of our software platform.
Previous experience in computer system validation or a similar role within a regulated industry, such as pharmaceuticals, medical devices, or biotechnology.
A bachelor's or master's degree in a relevant field such as Computer Science, Engineering, or a related discipline.
Qa Specialist Jobs
By Intellectt Inc At Alameda, CA, United States
Bachelor's degree preferred with 1 to 2 years of quality experience in medical devices.
Will consider an associate's degree but MUST have at least 2 to 4 years of quality experience in medical devices.
General exposure to quality systems is needed. - More than 4 yrs. of experience will be overqualified for this role.
Quality Experience in Med device
They are not investigating the complaint and just making sure it is properly documented.
Need to have Quality med device exp.
Qa Lab Specialist Jobs
By Solomon Page At Columbus, Ohio Metropolitan Area, United States
Able to interact with all levels of personnel and management (internally or externally)
Organizational, interpersonal, and communication skills.
If you meet the required qualifications and are interested in this role, please apply today.
Perform QC evaluations on individual products as compared to Standards
Perform inspections on products within the DCs
Evaluate test data gathered or received by supplier for compliance to standards
Qa Compliance Specialist Jobs
By Blackfield Associates At Massachusetts, United States

Blackfield Associates are currently supporting the hire of a QA Compliance Specialist with an established Biologics CDMO based in the Massachusetts area as a permanent member of the team. This ...

Qa Specialist Jobs
By Summit Biosciences Inc. At Lexington, KY, United States
Advises senior management on findings and recommendations related to internal and external auditing.
Manages the CAPA and Change Control Systems.
Performs activities associated with various one-time or on-going projects (from participation level to project manager).
Assists Manager with daily and project activities as needed.
At least 7 years Pharmaceutical/Medical Device cGMP quality experience
Knowledge of HPLC principles and ability to review data for accuracy and completeness
Csv Associate Jobs
By Integrated Resources, Inc ( IRI ) At Carlsbad, CA, United States
Update Validation schedules matrix in Asset management software (BMRAM).
Coordinate protocol, SOP and final report approval in the electronic document management system and track the process.
Seeking recent grad, or someone with 1-2 years of experience.
Experience with: PLC Programming, PID Controller, SCADA, Ladder Logic
Prepare validation binders prior and post- qualification protocol execution.
Execute and/or review qualification protocols with guidance as needed.
Remote Csv And Quality Systems Contractor
By Real Staffing At Boston, MA, United States
Supports Veeva workflow for GLP, GCP, GMP and medical device issue management
6-month contract with possibility to extend
Supports the drafting and reviewing of validation documents: URS, FS, CS, DS,TM, VP, VSR, protocols/test scripts
Executes/reviews change controls, risk assessments, CAPAs and deviations as owner or reviewer
Develops and maintains all training materials, training records and curriculums in Veeva
Supports Veeva users with system issues on a daily basis
Qa Specialist Jobs
By Sibel Health At Chicago, IL, United States
Develop process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
Min 6 years of related experience, including 3+ years experience in Quality Assurance and validation.
Experience performing internal audits and participating in external audits.
Effective verbal and written communication skills.
Working knowledge of regulations, standards and guidelines related to quality.
Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the business.
Specialist Iii, Qa Compliance
By BioSpace At Foster City, CA, United States
Good working knowledge of Quality Management System (QMS) fundamentals, processes, effects, and the relationship between the QMS and products.
Solid working knowledge of Electronic Document Management Systems (EDMS).
Manage the lifecycle of external supplier audit records in systems, ensure timely update and closure of audit records per procedural requirements.
Manage and process various activities in the Product Lifecycle Management system.
Work with manager on incorporating sound risk management principles for the establishment of the annual audit schedule.
Identify compliance risks and escalate issues to appropriate levels of management for resolution. Present escalations in stakeholder and management meetings.