Job Information
AMERICAN CYBERSYSTEMS INC. QA Associate Specialist - Document Control in Seattle, Washington
- Primary responsibilities include:
- Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting 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.
- Generate document management system reports for Quality Council metric reporting.
- Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
- Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
- Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles The ideal candidate will have:
- Bachelor's degree or equivalent
- Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
- 2+ years of Document Control & Reporting Experience
- 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)
- 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.). Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Aritra Roy 4702230481 [Aritra.Roy@innovasolutions.com]{target="blank" rel="noopener"} PAY RANGE AND BENEFITS: Pay Range*: $37.35- $38.15 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, a To view the full job description, https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEyMDM4Ljg3NjlAYWNzaWNvcnBjb21wLmFwbGl0cmFrLmNvbQ{nofollow"="" target="blank" rel="noopener"}">click here