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Quality Assurance Document Control Associate Jobs in Indiana

NCW

Quality Assurance Analyst

Indianapolis, IN

$25 - $30/hr

Support document control, training records, and continuous improvement initiatives within the ... QA, engineering support, or related technical experience * Ability to read and interpret ...

gaylor

Electrical QA/QC

Indianapolis, IN · On-site

Displays exceptional organization skills for record keeping and documentation purposes * Must be ... Maintains quality control procedures for each stage of the manufacturing and/or installation ...

Gaylor Electric

Electrical QA/QC

Lebanon, IN · On-site

Displays exceptional organization skills for record keeping and documentation purposes * Must be ... Maintains quality control procedures for each stage of the manufacturing and/or installation ...

gaylor

Electrical QA/QC

Lebanon, IN

Displays exceptional organization skills for record keeping and documentation purposes * Must be ... Maintains quality control procedures for each stage of the manufacturing and/or installation ...

gaylor

Electrical QA/QC

Indianapolis, IN

Displays exceptional organization skills for record keeping and documentation purposes * Must be ... Maintains quality control procedures for each stage of the manufacturing and/or installation ...

Mechanical Solutions

QA/QC Engineer

Lebanon, IN · On-site

QA/QC Manager Mechanical Solutions, Inc. (MSI) Full Time Lebanon, IN About Us: Mechanical Solutions ... Coordinate, document, and track preparatory, initial, and follow-up inspections * Lead, plan, and ...

INCOG

QA Associate, 3rd Shift

Fishers, IN

The QA Associate will need to provide support with identifying operational and quality gaps. The ... Review and approve documentation for Quality approval, including but not limited to on-floor batch ...

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Quality Assurance Document Control Associate information

What is a Quality Assurance Document Control Associate?

A Quality Assurance Document Control Associate is responsible for managing, organizing, and maintaining documentation related to quality assurance processes within an organization. They ensure that all quality documents, such as standard operating procedures (SOPs), work instructions, and records, are accurate, up-to-date, and comply with regulatory requirements. Their role often involves reviewing, issuing, archiving, and tracking documents, as well as supporting audits and ensuring that employees use the correct versions of documents. This position is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where document control is vital for regulatory compliance and quality management.

What are the main challenges Quality Assurance Document Control Associates face when managing document version control in regulated industries?

Quality Assurance Document Control Associates often encounter challenges ensuring all documents are current, accurate, and accessible to authorized personnel, especially in highly regulated industries like pharmaceuticals or medical devices. Managing version control requires meticulous attention to detail to prevent outdated documents from being used in production or audits. Additionally, coordinating timely reviews and approvals from multiple stakeholders can be complex, making strong organizational and communication skills essential for success in this role.

What are the key skills and qualifications needed to thrive as a Quality Assurance Document Control Associate, and why are they important?

To thrive as a Quality Assurance Document Control Associate, you need strong organizational skills, attention to detail, and familiarity with regulatory requirements, often supported by a degree in life sciences or a related field. Proficiency with document management systems (DMS), electronic quality management systems (eQMS), and standards such as ISO or FDA regulations is crucial. Effective communication, time management, and the ability to work meticulously under deadlines are valuable soft skills for this role. These competencies ensure the accuracy, compliance, and efficient handling of critical documentation, which is essential for maintaining quality standards in regulated industries.

What is the difference between Quality Assurance Document Control Associate vs Quality Assurance Specialist?

AspectQuality Assurance Document Control AssociateQuality Assurance Specialist
Primary RoleManage and maintain quality documentation, ensure document accuracy, control revisionsDevelop, implement, and monitor quality assurance processes and procedures
Required CredentialsTypically a high school diploma or associate degree; familiarity with document management systemsBachelor's degree in quality, engineering, or related field; certifications like CQE often preferred
Work EnvironmentOffice setting, regulated industries like pharmaceuticals, manufacturingLaboratory, manufacturing, or quality assurance departments in similar industries
Key FocusDocument control, compliance, record keepingProcess improvement, quality audits, compliance management

While both roles support quality assurance, the Document Control Associate primarily handles documentation and record management, whereas the Quality Assurance Specialist focuses on developing and overseeing quality processes. The Associate role is more administrative, while the Specialist role involves active process improvement and compliance oversight.

What cities in Indiana are hiring for Quality Assurance Document Control Associate jobs? Cities in Indiana with the most Quality Assurance Document Control Associate job openings:
Quality Assurance Document Control Associate jobs near you

Quality Assurance Administrator

Isotopia USA

Indianapolis, IN • On-site

Full-time

Re-posted 10 days ago

Job description

Job Title: Quality Assurance Administrator

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Indianapolis, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Administrator to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.

Responsibilities:

  • Management of a document control process for a cGMP manufacturing site.
  • Support the creation, formatting and approval of standard operating procedures, forms, and templates.
  • Creation and implementation of hard-copy and electronic filing systems for GMP drug manufacturing, including maintaining critical quality documents on and off site.
  • Support of GMP manufacturing processes, such as with release of incoming raw materials and issuance of batch records and test records.
  • Participation in creation of a site training program, and individual training files for employees, including GMP and GDP training.
  • Creation and maintenance of various document templates and databases.
  • Actively track and manage on-time record closure for critical records at the site.
  • Support the ongoing development and improvement of the quality management system (QMS).
  • Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Agency, Food and Drug Administration, etc).
  • Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.

Requirements

Education and Skills:

  • A minimum of an A.S. degree in the life sciences or business administration is required. B.S. degree is preferred.
  • Extensive experience and confirmed high-level competence with MS Word, Excel, and PowerPoint is required.
  • 3+ years working in a quality control or quality assurance position supporting GMP manufacturing is preferred.
  • Experience working in pharmaceutical or other regulated environments preferred.
  • Strong understanding of cGMP requirements is preferred.
  • Detail-oriented mindset with excellent organizational and record-keeping skills.
  • Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
  • Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
  • Flexibility to work in shifts and handle time-sensitive processes.
  • Strong commitment to safety, ethical conduct, and compliance with regulations.

Benefits

We offer a competitive salary, a comprehensive benefits package and advancement opportunity.

As an Equal Opportunity Employer, we are committed to a diverse workforce.