Sunrise Systems, Inc. · 1 month ago
QA Associate Specialist – Document Control
Bothell, WA
Full-time
Onsite
Mid Level
$36/hr - $44/hr
3+ years expSunrise Systems, Inc. is a company specializing in quality assurance and records management. They are seeking a QA Associate Specialist to support cGMP Document Control operations, ensuring the effective management of GMP records and assisting with audits and inspections.
Information Technology & Services
Responsibilities
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 Document Center Archive room activities
Knowledge of Records Management, Scanning and organization functions
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
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
Assist with Insurance and Reconciliation of Controlled Forms and Logbooks
Qualification
Required
Strong communication and customer service skills
Experience with Part 11 adherence regarding scanning of records and electronic archiving
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
Strong knowledge of cGMPs and domestic regulatory requirements
Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are required
Demonstrated experience with quality management systems
Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., Content Manager Records Software)
Bachelor's degree or equivalent. Library Science a plus. High school diploma/ associate's degree with equivalent combination of education and work experience may be considered
Minimum of 3+ years of relevant document control records management experience in a cGMP/FDA regulated environment
Benefits
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees.
We also offer Sick time benefits as required per State regulations.
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase