Description
Document Control Coordinator
(1-2 month project with possibility of becoming perm)
8:00 am-5:00 pm M-F
Mukilteo, WA
$20-$22.50/hr
Job Summary:
Join our dynamic team as a Document Control Coordinator, where you will play a pivotal role in ensuring the integrity and accuracy of our quality documentation. Located in a fast-paced biotech environment, this individual contributor position will support the Sr. Manager of QA in maintaining and distributing vital quality reports and documentation. If you have a keen eye for detail and a passion for quality assurance, this is an exciting opportunity to make a meaningful impact!
Job Specifications:
- Location: Mukilteo, WA
- Pay Rate: $20-$22.50/hr
- Shift: 8:00 am-5:00 pm
Roles and Responsibilities:
- Review change order submissions for completeness and accuracy, ensuring compliance with established processes.
- Identify gaps in the change order process and recommend effective solutions.
- Assist in preparing, tracking, and distributing various quality reports, logs, and databases.
- Ensure adherence to Change Order procedures and Documentation Standards.
- Collaborate with departmental managers to train employees on new or revised documents.
- Maintain training records and track employee completion status of training assignments.
- Lead the records management program, including archival activities and external storage shipments.
- Manage online document repository systems related to change requests and QA/RA activities.
- Provide support during internal and external audits and regulatory inspections.
- Assist in the preparation of documents required to standardize business processes and satisfy regulatory requirements.
- Support other departmental personnel with administrative duties and data entry as needed.
SPECIFIC KNOWLEDGE & SKILLS:
- Ability to learn and apply GMP and SOP concepts during day-to-day processes.
- Communicate clearly and effectively both orally and in writing with internal and external clients.
- Strong understanding Quality Management systems and Regulatory requirements impacting the medical device industry, including ISO 13485 and FDA regulations.
- Ability to work across numerous scientific and management disciplines.
- Good Computer Skills
- Must be knowledgeable of industry documentation types and Good Documentation Practices (GDP).
- Microsoft Suite, proficiency
GENERAL SKILLS & COMPETENCIES:
- Detail-oriented, organized and applies effective time management skills in order to meet all deadlines.
- Able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
- Basic Understanding of current FDA and GMP / GLP regulations.
- Oral and Written Communications, Action Oriented; Organization, Teamwork
- Must be able to work independently with minimal supervision and in a team-oriented environment.
- A minimum of 3 years of Quality Assurance, Document Control, Records Management and Archiving experience in a biotech or pharmaceutical company.
- Experience with electronic change control systems.
- Strong knowledge of Microsoft Word, Excel, Visio, and Adobe Acrobat
#CB #P1 #P2
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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