QA Document Control Labeling Specialist

Immediate need for a talented QA Document Control Labeling Specialist. This is a 06+ months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-22574

Pay Range: $48 - $56/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key 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 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

Key Requirements and Technology Experience:

• 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
• Education: Bachelor s degree or equivalent
• Experience Basic Qualifications:
• 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

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.