- Issuing production batch records, labels, and other controlled documents to support manufacturing operations
- Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
- Assist with managing the Document Center Archive room
- Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and 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. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections
- Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
- Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders
- Strong communication and customer service skills.
- Innovation
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively
- Smartsheet and Excel experience
- Ability to provide examples on how they have honed in on attention to detail
- Review of SOPs, procedures, edits and annotations within EDMS experience
- 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
- Some labeling experience strongly preferred
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Quality Assurance Document Control - Bothell, United States - On-Board Companies
Description
On-Board Services is hiring aQuality Assurance Document Control (QADC) Associate Specialist
in Bothell, WA
For immediate consideration please send your resume to
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.
Position Details:
Position Type:
Quality Assurance Document Control (QADC) Associate Specialist
Job Location:
Bothell, WA
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation:
$ $61.24 /hourly (based on experience)
Duration: 12 – month
Shift-Friday- Monday 6am-2:30pm
Description:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
Responsibilities:
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.
Qualifications:
Top Skills:
Education:
Bachelor's degree or equivalent
Experience Basic
Qualifications:
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.
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