Job Description

QA Specialist
Job Number: 21-16210
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Specialist for our client in Bothell, MA. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • The Quality Assurance Document Control (QADC) Labeling Specialist supports the cGMP Document Control operations for the Client Jump site, including the coordination, issuance, reconciliation, and management of production labels and records.
  • To succeed in this role, you will have a strong attention to detail and an analytical mindset.
 
Qualifications:
  • Education: Bachelors degree or equivalent
  • Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment
  • Some document management experience
  • Crystal reports experience preferred
  • Strong communication and customer service skills.
  • 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)
  • Develop and improve label issuance processes to drive operational efficiency
  • 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 be able to complete tasks independently and communicate with manager on decisions outside of established processes and the ability to build an internal network
 
Responsibilities:
  • Issuing production labels, batch records, and other controlled documents to support manufacturing operations
  • Coordination of work activities to support manufacturing
  • 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.
  • 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
  • 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
  • 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
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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