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Document Control Specialist
$79k-111k (estimate)
Full Time 7 Months Ago
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Edgewise Therapeutics is Hiring a Document Control Specialist Near Boulder, CO

Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage pharmaceutical company focused on rare muscle disorders.
About the Position
Edgewise Therapeutics is seeking a highly-motivated and self-directed Quality professional, In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of pharmaceutical products. The ideal candidate will have significant experience in Quality Assurance Document Management and electronic systems. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
To learn more about or story and company culture, visit us at https://edgewisetx.com
Essential Duties and Job Functions
  • Manage and develop improvements to the Electronic Document Management System (EDMS), including electronic and hardcopy documents
  • Thorough knowledge and experience in Veeva Vault QualityDocs and QMS software
  • Ensure Document Control (DC) procedures comply with regulatory guidelines including 21 CFR Parts 11, 210, and 211, Eudralex Volume 4, and ICH Q7.
  • Provide Doc Control training to staff.
  • Be an expert with the EDMS and collaborate consultants and vendors drive improvements and solve problems.
  • Lead and guide troubleshooting for complex DC-related issues and systems.
  • Maintain all document files, as related to the company, and assists in the archival of documents.
  • Lead projects or tasks delegated by Associate Director, Quality Assurance, as requested.
  • Takes an ownership role and drives process improvements within EDMS, or other areas of support.
  • Trains/mentors less experienced personnel in technical concerns, as well as personal development.
Education & Experience
  • Bachelor’s degree in life science discipline and five years related experience
  • Prior experience working in a GMP production environment required
  • Experience with Microsoft products (Word, Access, Vizio, Excel, and PowerPoint), Adobe Pro, and the internet
  • Electronic Document Management System (EDMS) experience, including training others
  • Effective communication, both written and verbal skills; ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers
  • Project management skills, including prioritization and experience setting standards
  • Knowledge of GMP guidelines and ICH regulations pertaining to the production of drug substances and drug products
Working Conditions
Open for remote but occasional in-office work to manage archival of hard copy documents will be required
Salary Range: $70,000 - $115,000. Level and salary will depend on experience level.

Job Summary

JOB TYPE

Full Time

SALARY

$79k-111k (estimate)

POST DATE

10/13/2023

EXPIRATION DATE

06/05/2024

WEBSITE

edgewisetx.com

HEADQUARTERS

Boulder, WY

SIZE

<25

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The job skills required for Document Control Specialist include Document Management, Quality Assurance, Project Management, PowerPoint, Adobe, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Document Control Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Document Control Specialist. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Document Control Specialist positions, which can be used as a reference in future career path planning. As a Document Control Specialist, it can be promoted into senior positions as a Document Control Analyst III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Document Control Specialist. You can explore the career advancement for a Document Control Specialist below and select your interested title to get hiring information.

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If you are interested in becoming a Document Control Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Document Control Specialist for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Document Control Specialist job description and responsibilities

Document control specialists store, manage and track records and documents for government agencies and engineering firms.

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A document control specialist makes sure their organization follows document retention policies and retrieves those documents upon request.

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Document control specialists must also manage the computer software used to manage the organization’s documents.

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Document Control Specialists are also responsible for scheduling, labeling, filing, pulling, distributing, and recovering documents.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Document Control Specialist jobs

An outstanding document control specialist checks the promptness and approval of documents, and ensure their timely turn over.

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A document controller specialist who never opens the documents to check them only does half of the job.

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Obtain a strong experience as a document controller.

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Step 3: View the best colleges and universities for Document Control Specialist.

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