Address
Form of workImmediate need for a talented QA Associate Specialist – Document Control. This is a 10+ MonthsContract 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: 24-08492
Pay Range: $45- $50/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:
- 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.
- Thorough 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.
- 5+ years of experience with the following:
- Library Science.
- MS Office including Word, Adobe, Visio.
- Document Scanning experience.
- FDA Documentation & Compliance like 21 CFR Part 11/CGMP.
- Ability to manage competing priorities.
- Accuracy and Attention to Detail.
- Education: Bachelor’s degree or equivalent. Library Science a plus.
- Minimum of 5 - 8 years of relevant Document Control records management experience in a cGMP/FDA regulated environment.
- 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.
- Possess project management skills.
- 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.
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.
