Quality Assurance Document Control Associate II

1 week ago

Lexington, United States Genezen Full time
Job DescriptionJob Description

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.

WORKING AT GENEZEN

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 Associate II will support both the GxP and development areas of uniQure for aspects relative to document management. Responsibilities include formatting and processing of new and revised documents, processing of retired documents, issuance and verification of controlled documents, scanning/verification and archiving of controlled documents. The QA Document Control Associate II is expected to work proactively with various departments to help ensure understanding of 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

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 or 2-4 years of experience in Document Control or related area preferred

Essential

ON-THE-JOB EXPERIENCE

2-4 years of experience in Document Control or related area preferred

Essential

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
    Communication
  • 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
  • 9 observed holidays + 1 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.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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