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Senior Quality Systems Specialist Jobs

Quality Systems Specialist Jobs
By Legend Biotech At Somerset, NJ, United States
Perform configuration and change management activities in support of vendor enhancements and customer requirements.
IT System Administration/Vault Owner in Veeva vault (Quality, RIM, Clinical), learning management system, validation lifecycle management system, electronic signature systems.
Validation Lifecycle Management System (ValGenesis, HP ALM, etc.), Change control, document management systems (Veeva, Documentum, etc.), DocuSign/Adobe Sign.
Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3 to 5 years’ experience.
Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
Ability to interpret and apply GxPs, regulatory requirements, Computer Systems Validation (CSV), SDLC, and industry best practices.
Quality Systems Senior Analyst
By Pfizer At North Carolina, United States
Identifies issues and reports them to appropriate management attention immediately
Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
Capability of understanding requirements of LIMS builds
Good judgment and correct decision making based on Pfizer procedures, PQSs, technical experience; and industry guidance/regulatory regulations
Effective written and verbal communication and interpersonal skills
Interface with and represents QO in cross-departmental and cross-site meetings, manage working area and projects/changes to accomplish change activities/project deliverables
Quality Systems Specialist Jobs
By Adicet Bio At , Redwood City $93,000 - $129,000 a year
Review and process documents to ensure adherence to document management procedural requirements (e.g. formatting, templates) and document life-cycle.
Experience working with electronic Document Management Systems such as Veeva, TrackWise, MasterControl, ComplianceWire or others similar is preferred.
Ability to work cross-functionally with colleagues of various levels of experience and management.
Provides end-user support, guidance, and training on Document/Records/Training Management processes.
Manage periodic review process to ensure controlled documents are up to date with internal and regulatory requirements.
Knowledge of GxP, ICH, EU and CFR requirements and regulations.
Quality Systems Specialist Iii
By Bio-Rad Laboratories, Inc. At , Richmond, 94804 $80,000 - $110,000 a year
Work Experience: 4+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
Proper review of Qualification / Validation documents in SAP PLM.
Education: Associate degree or equivalent in Biology, Chemistry, or related field.
Self- driven: no need to be micro – managed and can have personal initiative to prioritize work activities.
Timely Product releases from manufacturing to distribution
Correct processing of Quality Notifications (Deviations and Non- conformances)
Quality Systems Specialist Jobs
By Zoetis At , San Diego $71,000 - $108,000 a year
Compiles quality metrics for monthly quality councils and annual management reviews.
2-5 years related experience preferably in a USDA or FDA regulated industry.
Must possess strong oral and written communication skills and the ability to work independently.
Must have experience with Internal and External Audits.
Ability to effectively review in-process and product final testing to ensure compliance with requirements.
Strong computer skills including Outlook, PowerPoint, Excel, Word.
Quality Systems Specialist Jobs
By Regeneron At , Troy, 12180
Excel in time and project management skills with the ability to manage many diverse tasks simultaneously.
Excel at written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
Have a broad knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
Review of system records for assignment and closure.
Assisting Senior Quality Systems employees in support of maintaining, monitoring and improving quality system elements. This may include support in:
Assisting with the delivery of training, such as scheduling training sessions, maintaining rosters and collecting feedback.
Quality Systems Specialist 3 (Contract)
By Boeing At , Jacksonville, 32244

Documents and maintains completed build/quality/inspection records to maintain the integrity of as-built deliverable product configuration. Reconciles erroneous data entries to ensure all ...

Senior Manager, Quality, Quality Management Systems
By GE Healthcare At , Chicago, 60661
Experience leading and implementing change. Experience performing internal audits and participating in external audits.
Established expertise within all Medical Device QMS processes.
Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device facility.
Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
Associate Quality Systems Specialist
By BOEING At , Saint Charles $71,100 - $86,900 a year
Knowledge of, or experience working with DCMA (Defense Contract Management Agencies)
Researches contractual and Boeing Quality Management System requirements for applicability to specific proposals and program processes and documentation.
1 or more years of experience with AS9100 or similar QMS (Quality Management Systems)
Develops sections of quality metrics, design and production certification plans to ensure compliance with contractual, Company and regulatory requirements.
1 or more years of experience working in a manufacturing environment
Experience working on RCCA’s (Root Cause Corrective Actions)
Associate Quality Systems Specialist
By Medtronic At , Fridley, 55432
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
0 years of experience required
Responsibilities may include the following and other duties may be assigned.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Co-ordinates legal requests in support of government investigations or litigations.
Senior Manager, Quality Systems
By Bristol Myers Squibb At , Summit, 07901
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
Equivalent combination of education and experience acceptable
Provide support for activities using the electronic Deviation and CAPA management systems
Review of SOPs, Work Practices and other types of documents as required. Performs supplemental investigations/projects as required by management.
Act as primary link to other CTDO sites to ensure Deviation and CAPA management process is properly implemented and consistent
Quality Systems Specialist Ii
By Pyros Pharmaceuticals At , Remote
In-depth knowledge of Regulatory/Compendial requirements, pharmaceutical quality, and Quality Systems, with broad experience and exposure to best practices is required.
Escalates potential risks to management during planning, review, data validation, data review, and archival processes.
Technical experience of working at a manufacturing facility with the ability to understand and interpret regulatory requirements is required.
Assists as needed with maintaining the supplier qualification process.
Experience with cGMP documentation is required.
Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required.
Specialist, Quality Systems & Compliance
By Astellas At , Sanford
The Specialist, QA Systems and Compliance will report to the Sr. Manager, Quality Systems and Compliance
Executes supplier audits and implements Astellas requirements where applicable.
Perform other support responsibilities as requested to support Quality and Regulatory oversight activities.
Proven ability to manage multiple projects while maintaining quality
Strong interpersonal skills with reputation for collaboration with colleagues
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
Quality Systems Specialist Jobs
By Ocugen Inc At , , In
Manage the Veeva QMS state of compliance including change management and validation.
Assist with preparation and facilitation of Management Review meetings.
Provide administrative back up for the Document Control Specialist for the electronic Quality Document Management system (Veeva Vault QualityDocs).
Auditing experience with certification preferred.
Manage Veeva account requests, creation, and modifications.
Quality trending, metrics generation, and KPI experience.
Quality Systems Specialist Iii
By Takeda Pharmaceutical At , Brooklyn Park, Mn
Identify, investigate, and resolve complex technical issues using problem-solving skills. Notifies management of actions taken.
Analyze and interprets projects, studies, or investigations to determine next steps. Make decisions and notify management of action taken.
Receive overall project direction from management but complete most work independently.
You will support and deliver training on quality management procedures and workflows (e.g., deviation, OOS, CAPA).
5+ years' experience in Regulated (food, medical device, or pharma/biotech) industry.
Direct experience with Quality Assurance within the Life Science industry.
Senior Quality Specialist Jobs
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
Quality Systems Specialist 3 Jobs
By Moseley Technical Services, Inc. At Jacksonville, FL, United States
Bachelor's Degree combined with 5 + years of relevant work experience; or an equivalent combination of technical education and experience.
Monitor work of less experienced employees.
Maintain records storage and shipping logs to assure retrievability in compliance with applicable requirements.
Document and maintain completed build/quality/inspection records to maintain the integrity of as-built deliverable product configuration.
Provide product build information to status the product for roll out, flight and/or delivery.
Let us help you to elevate your career by joining our team!
Senior Quality Specialist Jobs
By Fraser Dove International At Denver Metropolitan Area, United States
Project management experience although not required is beneficial to this position.
Ability to communicate information to customers and senior management.
Ability to effectively present information to top management, and public groups.
Knowledge of cGMP, cGLP and FDA regulations, as well as internal quality-related procedures.
Practical and theoretical knowledge of the basic principle of validation and its applications.
Excellent verbal, presentation, and written communication skills.
Senior Quality Specialist Jobs
By nextgen At Texas, United States
Knowledge of Software Quality Assurance or Software Engineering Methodologies.
Reviewing and interpreting business requirements and design specifications and translating them into test procedures.
Good communication skills (interpersonal, listening, written and oral), be self-motivated, organized, thorough, and efficient.
Skill with application testing using SQL, PL SQL.
Skill with testing of applications designed in Java, and .NET.
Skill with developing Web application testing automation using Java and Selenium, or similar.
Quality Systems Specialist - Jax
By Boeing At Jacksonville, FL, United States
Supports quality source selection and process reviews of suppliers' ability to meet program quality requirements
5+ years’ experience with U.S. Navy or USMC aviation logistics, maintenance and acquisition practices
Experience with 4790.2 Naval Aviation Maintenance Program (NAMP)
5+ years’ experience maintaining P-8A Aircraft Logs, and Records Books IAW 4790.2
5+ years of experience with P-8A, QAS, Full Systems QAR, CDQAR or CDI
Experience with MPA or CNAL audits