Quality Assurance Document Control & Training Associate
Genezen
- United States
- United States
Über
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. Job Summary
The QA Document Control/Training Associate will support both the GxP and development areas of Genezen for aspects related to document management and training. The role is expected to work proactively with various departments to help ensure understanding of training, document management procedures and software to ensure that documentation requirements are consistently met in a timely manner. Essential Job Functions
Perform document administrator functions within Electronic Document Management System Format documents in accordance with approved templates and procedures Issue and verify controlled documents and unique identifiers (including lot numbers and labels) Perform archival, scanning, and tracking of physical documents Revise/Develop policies and procedures for document control system in support of Quality Management System as needed Submit and request documents to/from off-site storage Provide support and training as need for use of the EDMS Provide support for inspections including tracking inspection requests, document retrieval, and generation of official copies Track documents relative to expiration/review periods Maintain training on documents relative to job functions Perform other related duties and responsibilities as needed Coordinates onboarding activities for new hires. Helps maintain and improve onboarding process for new hires. Assist with Training Department requests including, but not limited to: report requests, training verifications, training approvals, updates in the EDMS etc. Tracks, maintains, and files completed training forms and employee training files. Strong interpersonal skills and an ability to interact professionally with team members of various professional levels. Special Job Requirements
Experience in GxP environment. Document review and GxP procedural writing experience. Proficient with Microsoft Word, Excel, Outlook, and Adobe Acrobat. Experience with Veeva preferred. Adaptability required as work schedule may change based on business needs. Criminal background check required. Other duties as assigned. Knowledge, Skills and Experience
Education / Certifications / Licenses
Essential/Desired
Bachelor's degree Desired
On-the-Job Experience
1 - 2 years of experience in Document Control or related area preferred Desired
Skills / Abilities
Understanding of office processes, including filing, record management and archiving of documentation Essential Attention to Detail Essential Strong communication and customer service approach Essential Organizational Skills Essential Time Management Essential Self-directed and motivated Essential Ability to work overtime as needed Essential
Physical Demands
While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Regularly sit for long periods of time. Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 pounds Occasionally lift and/or move up to 25 pounds Vision Frequently utilize close vision and the ability to adjust focus Frequently required to communicate by talking, hearing, using telephone and e-mail Genezen's Cures Value-Based Competencies
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. Genezen's Benefits
Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance Additional Details
Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Sprachkenntnisse
- English
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