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Experienced 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 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 ...

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.
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.
Experienced Quality Production Specialist - Investigations
By BOEING At , North Charleston, Sc
2+ years of experience in a production-related field such as Manufacturing, Quality, Production Engineering, Supplier Management, and/or Supplier Quality
Review and validation of product non-conformances and disposition type, quality procedures and engineering requirements.
2+ years of experience with conducting quality investigations, Root Cause analysis and implementation and verification of Corrective Actions in production environments
2+ years of experience using all the following Microsoft Office Applications (Word, Excel and Outlook)
2+ years’ experience developing presentations for senior leadership
Experience working directly with suppliers.
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.
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.
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Quality Management Systems Specialist
By Elevation Labs At Denver, CO, United States

About Us What do we consider our greatest asset? Our passionate team members With a vision of creating quality skincare and cosmetic products for the most popular brands in the world, our founders ...

Specialist, Quality Systems And Compliance
By Moderna At Norwood, MA, United States
Support Quality Management Review, Annual Product Review, Deviation Review Board, Change Review Board and CAPA review board initiatives.
BA/BS degree (preferred) with at least 2 years of Quality Assurance working experience in pharmaceutical industry providing Quality Assurance oversight.
Demonstrated data analysis and analytical tool experience.
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
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
Quality Systems Specialist Jobs
By IntelliGuard® Intelligent Inventory Solutions At San Diego, CA, United States
Conduct employee training on applicable Quality SOPs and regulatory requirements under the guidance of Quality Management
Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program.
Must have excellent skills in organization, negotiation, problem solving and time-management.
Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls).
Report to management all quality issues, trends and/or losses
Other duties as assigned or identified by Quality Management.
Senior Quality Systems Specialist
By Pfizer At , Andover, Ma
Knowledge of regulatory change management including common board of health reportability requirements
Knowledge of DMAIC process, lean principles and quality risk management.
Responsible for front line decision making for site change records and regulatory change management
Provide support to other site quality systems including investigations/CAPAs, document management, training, and product complaints as required
Requires no supervision for routine assignments and recognizes when management involvement is necessary
A team player with excellent interpersonal, organizational, and communications skills (verbal and written)
Quality Systems Specialist Jobs
By ttg Talent Solutions At , Hialeah Gardens, Fl $25 an hour
2-4 years min of related work experience or an equivalent combination of formal education, on-the-job training, and/or work experience
Working knowledge of MS Office Suite
Knowledge of lean principles (preferred)
Team with Global co-workers to ensure that new product requests are completed in a timely fashion.
Review and audit system data to ensure product profiles are accurately maintained and update as needed.
Review and action requests to re-profile product and escalated new part requests.