ZipRecruiter

Log In

1

Quality Assurance Document Control Associate Jobs in Indiana

PTS Diagnostics

Be Seen First

Document Control Associate

Indianapolis, IN · On-site

SUMMARY The Document Control Associate is responsible for maintaining the integrity of the Quality ... This role ensures Quality System documentation is accurate, current, properly approved, and ...

New

Real Soft, Inc.

Document Controller

Indianapolis, IN · On-site

Qualifications The experienced Document Controller supports the GQC QA Operations team by managing the full lifecycle, control, and governance of quality documentation required for compliance with ...

System One

Document Controller

Indianapolis, IN · On-site

$34.94 - $41.11/hr

Owns and manages the end-to-end document control lifecycle for QA documentation, including creation, revision, review, approval, issuance, archiving, and retirement, in compliance with GQS and LQS ...

DHL

Quality Assurance Supervisor

Whiteland, IN · On-site

... document control, and standard operating procedures/work instructions. * Provide support on key ... Supervise, coach, and train hourly associates supporting quality assurance and control activities ...

DPDHL

Quality Assurance Supervisor

Whiteland, IN

... document control, and standard operating procedures/work instructions. * Provide support on key ... Supervise, coach, and train hourly associates supporting quality assurance and control activities ...

Central Wire

Quality Assurance

Michigan City, IN · On-site

$17/hr

... calibrations, training, safety, lean/6S, and document control. Essential Duties and ... Associates Degree preferred * Bachelor's Degree and/or additional experience will be given extra ...

Goyette Mechanical

QA/QC Lead

Hobart, IN

The QA/QC Lead Position The QA/QC Lead oversees a team of QA/QC agents and leads QA/QC operations ... This role performs and leads field inspections, documents observations in Procore, and communicates ...

INCOG BioPharma Services

QA Associate

Fishers, IN · On-site

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

INCOG

QA Associate

Fishers, IN · On-site

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 ...

next page

Showing results 1-20

All JobsQuality Assurance Document Control Associate JobsQuality Assurance Document Control Associate Jobs in Indiana

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
QA Document Control Specialist

QA Document Control Specialist

SpectronRx

Bunker Hill, IN • On-site

$26 - $29/hr

Full-time

Posted 21 days ago

Job description

Quality Assurance Document Control Specialist
COMPANY OVERVIEW
SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. We are seeking an experienced QA Document Control Specialist to join our growing company. The QA Document Controller will Assist with the management and follow-up of the Quality Assurance System and/or Product to guarantee the compliance with SOPs, policies, and Quality agreements.
ESSENTIAL FUNCTIONS
  • Control of distribution of released documents.
  • Manage the flow of documents, from issuance to filing/archival.
  • Ensure documents are readily accessible and up-to-date
  • Securely filing hard copy originals, superseded hard copy originals and supporting documents.
  • Act as electronic database administrator and provide support as needed for the database.
  • Control electronic database uploads of items as required.
  • Ensure that all product review, CAPA, OOS, Deviation, and Change Control documentation is filed as applicable.
  • Control the filing of all supporting documents (including but not limited to specifications, labels,
  • MSDS, USP chapters, FDA references and FDA applications)
  • Ensure that the corporate QA document file is updated.
  • Minute all QA related meetings, coordinate attendee sign off as required and file.
  • Coordinate the collection and distribution of consultant work orders and invoices.
  • Assist purchasing to establish an approved supplier list.
  • Assist as required with all QA activities.
  • Performs other related duties as assigned.
  • Physical Ability – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
  • Attention to Detail – Ability to accurately count, verify, and record data.
  • Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
  • Speaking – Talking to others to convey information effectively.
  • Time Management – Managing own time to prioritize tasks and meet deadlines.
  • Coordination – Adjusting actions in relation to others’ actions in a team environment.
  • Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Written Comprehension – The ability to read and understand information and ideas presented in writing.
  • Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
  • Organizational Skills – Ability to maintain orderly areas and accurate records.
TRAVEL
  • Regular travel is minimal.
REQUIRED EDUCATION AND EXPERIENCE
  • High school diploma or equivalent education required.
  • Proficiency in Microsoft office (Microsoft Word, Excel, and Outlook, Microsoft PowerPoint) and Adobe Acrobat required.
  • Excellent customer service
  • Excellent communication and organizational skills.
  • Ability to train and be trained.
  • Strong attention to detail.
  • Excellent organizational skills and attention to detail.
PREFERRED EDUCATION AND EXPERIENCE
  • Familiarity with a manufacturing or production environment.
  • College Degree Preferred.
  • Certificate in quality assurance is a plus.
  • Have Good knowledge of cGDP and cGMP
ADDITIONAL REQUIREMENTS
  • Valid Indiana driver’s license.
  • Pass a Background Check.
  • Prolonged periods of standing, walking, bending, and lifting.
ADDITIONAL INFORMATION/BENEFITS
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
  • We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process.
  • We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.

Apply