Job DescriptionQA Document and Labeling Specialist
Category:
Life Science
Employment Type:
Contract
Reference:
BH-373445
QA Document and Labeling Specialist
BMS ID # 58339-1
Bothell, WA- ON SITE
6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $50-56/hour - Depending on Education and Experience
Summary:
Shift- Sunday - Thursday 10:00pm - 6:30am
Top Skills:
* 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
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:
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 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
Skills or Requirements:
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
Education/Experience:
Bachelor's degree or equivalent.
Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
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.
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.