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Form of workOn-Board Scientific is hiring a QA Associate Specialist – Document Control, Bothel, WA!For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position, Title, and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Actual Job title: QA Associate Specialist – Document Control
Position Type: Full Time / 11-month contract
Job location: Bothell, WA
Shift: 1st shift 8am-4:30pm Mon-Fri
Compensation: $40-43.90 hourly (Based on Experience)
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Bothell site, including the document change control process as well as review and approval of documents within the document management system.
DUTIES AND RESPONSIBILITIES:
• Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
• May write and revise Document Control procedures including participating in the development and roll-out of Document Control tools.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
• Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
• Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
WORKING CONDITIONS (US Only):
Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shift support may be required.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Education: Bachelor’s degree or equivalent
• Minimum of 1 year of relevant Document Control management experience in a cGMP/FDA regulated environment
• Strong communication and customer service skills.
• Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.
JD# 23-03361
Subject Line: Position, Title, and State you are Located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Actual Job title: QA Associate Specialist – Document Control
Position Type: Full Time / 11-month contract
Job location: Bothell, WA
Shift: 1st shift 8am-4:30pm Mon-Fri
Compensation: $40-43.90 hourly (Based on Experience)
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Bothell site, including the document change control process as well as review and approval of documents within the document management system.
DUTIES AND RESPONSIBILITIES:
• Managing an electronic document system for the Bothell site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
• May write and revise Document Control procedures including participating in the development and roll-out of Document Control tools.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
• Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.
• Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
• Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
WORKING CONDITIONS (US Only):
Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shift support may be required.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Education: Bachelor’s degree or equivalent
• Minimum of 1 year of relevant Document Control management experience in a cGMP/FDA regulated environment
• Strong communication and customer service skills.
• Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Able to prioritize, manage time well, multi-task, and troubleshoot effectively
• Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
• Possess project management skills.
• Experience interacting with FDA or other regulatory agencies strongly preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
• Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
Apply Today!
www.onboardusa.com
www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.
JD# 23-03361
