CHC PR & MSA NW WashingtonLynnwood, 14 mi from Everett
Administration or similar, or Clinical discipline
• Preferred experience in post acute care
• Minimum of 5 years' experience in healthcare management preferred
• Excellent skills needed in forecasting, market based planning, communications and public relations...
SpindleMarysville
Join Our Team: Immediate Openings for Substitute Paraprofessionals.Are you seeking flexible work opportunities in education? Our recruiting agency is currently seeking Substitute Paraprofessionals to support schools in Washington.If you're passionate about making a difference in students' lives and ...
SpindleMarysville
Now Hiring: Substitute Paraprofessionals for K-12 Schools in Washington.Are you seeking flexible work opportunities in education? Our recruiting agency is currently seeking Substitute Paraprofessionals to support schools in Washington.If you're passionate about making a difference in students' lives...
Core Medical GroupMill Creek
EMR - Clinicient CoreMedical Group has hundreds of exciting and rewarding travel assignments throughout the country for Travel Allied Professionals and Travel Nurses.Plus, we're the only healthcare staffing company to offer our travelers a free, all-inclusive tropical vacation.You can earn our Club ...
The Pokémon Company InternationalBellevue, 26 mi from Everett
YouTube (), Twitter (), and Instagram ().
Get to know the role
• Job Title: Associate Public Relations Manager
• Job Summary: This role is responsible for supporting PR initiatives and campaigns across the Pokémon brand's portfolio of consumer products...
CareerStaff UnlimitedSeattle, 28 mi from Everett
to:
• Demonstrate excellence in customer service and public relations to promote a positive professional image
• Work independently with attention to detail and possess the necessary knowledge of all aspects of daily operations
• Foster a caring environment...
CareerStaff UnlimitedSeattle, 28 mi from Everett
to:
• Demonstrate excellence in customer service and public relations to promote a positive professional image
• Work independently with attention to detail and possess the necessary knowledge of all aspects of daily operations
• Foster a caring environment...
Overlake Terrace Retirement CommunityEverett
but if you have experience in hospitality, property manager, hotel manager, event sales we would love to hear from you!
• Associates or Bachelor’s degree in business, business administration, public relations, communications, sales, marketing or related field...
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Computer Validation Specialist
Bothell | www.resume-library.com |
Responsibilities:
The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions.
This role is an individual contributor with occasional oversight of contract resources on a project basis.
The CSV Engineer partners with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems.
The CSV Engineer has primary responsibilities to ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations.
This includes leading computer system validation efforts for new system implementations and changes to existing systems as well as coordinating system validation assessments, periodic reviews, and audit activities
Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR
Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Requirements:
Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
3. 5+ years' experience in performing periodic review of computerized systems.
Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
Strong critical thinking and problem-solving skills
Strong interpersonal skills to work with teams in different functions and organizations.
GXP Equipment Validation
Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
Author, review and/or approve applicable CSV documentation.
Perform or oversee test script execution efforts, including defect management.
Ensure validation test strategies align with internal procedures and requirements for intended use.
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
Experience in following CSV methodology for system evaluations, changes, and implementations.
Ability to work independently.
Other related duties as assigned.
The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions.
This role is an individual contributor with occasional oversight of contract resources on a project basis.
The CSV Engineer partners with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems.
The CSV Engineer has primary responsibilities to ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations.
This includes leading computer system validation efforts for new system implementations and changes to existing systems as well as coordinating system validation assessments, periodic reviews, and audit activities
Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR
Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Requirements:
Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).
3. 5+ years' experience in performing periodic review of computerized systems.
Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
Strong critical thinking and problem-solving skills
Strong interpersonal skills to work with teams in different functions and organizations.
GXP Equipment Validation
Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance [CSA]), and good understanding of electronic record / signature management practices.
Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
Author, review and/or approve applicable CSV documentation.
Perform or oversee test script execution efforts, including defect management.
Ensure validation test strategies align with internal procedures and requirements for intended use.
Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
Experience in following CSV methodology for system evaluations, changes, and implementations.
Ability to work independently.
Other related duties as assigned.
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