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11 days old

Document Control Specialist

Kelly Services
Bothell, WA 98021
QA Document Control Associate Specialist

**Contract Length:** 1 year from start date



**Location:** Bothell, WA




**Job Description** :

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Manufacturing Plant, including the issuance and reconciliation of batch records, labels and batch related forms, document change control process, and management of archival and retention of GMP records


**Education:** Bachelors degree or equivalent


**Experience Basic Qualifications:**




+ Minimum of 1 years of relevant document control management experience in a cGMP/FDA regulated environment

+ Must have a strong technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

+ Must have strong attention to detail

+ Innovative, proactive, and resourceful; committed to quality and continuous improvement

+ Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables

+ Able to successfully manage multiple priorities

+ 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)




+ Knowledge of cGMPs and domestic regulatory requirements

+ Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)

+ Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build an internal network. **Primary responsibilities include:**

+ Issuing controlled documents such as production batch records, controlled forms, logbooks and labels to support manufacturing operations
Filing and scanning of controlled documents

+ Maintaining the GMP document storage room, the organization of associated document files and ensure that records are readily retrievable

+ Execute the process and procedures for identifying, collecting, distributing, and filing the controlled documents for the site

+ Managing an electronic document system which includes creating and approving document change requests, formatting documents, managing document workflows through the appropriate lifecycle, and releasing documents to an effective state

+ Writing and maintaining document control procedures and 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

+ 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




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-09-07 Expires: 2020-10-08

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Document Control Specialist

Kelly Services
Bothell, WA 98021

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