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Quality Assurance Document Control Associate Jobs in Minnesota

Pace

PLS Document Control Specialist

Oakdale, MN · On-site

$40K - $45K/mo

This is an onsite, full-time, PLS Document Control Specialist position located in Oakdale, MN ... Quality Assurance Specialist I Pace ® Analytical Life Sciences (PLS) is an industry leading ...

Pacelabs

PLS Document Control Specialist

Oakdale, MN

$40K - $45K/mo

This is an onsite, full-time, PLS Document Control Specialist position located in Oakdale, MN ... Quality Assurance Specialist I Pace Analytical Life Sciences (PLS) is an industry leading contract ...

New

Actalent

Document Control Coordinator

Mankato, MN

$25 - $35/hr

Support the implementation and integration of quality processes within the ERP system. Essential Skills * Experience with data entry, document control, or ERP systems. * Strong Microsoft Excel skills ...

Integer

Document Control Administator

Plymouth, MN

$24.59 - $36.07/hr

Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food ... motivate associates to contribute to Integer's success. Our compensation program includes base ...

North Freeze Dry LLC

QA Associate

Little Falls, MN · On-site

$21 - $24/hr

Quality Assurance Associate Purpose of Position This is an in office position, Not hybrid. Will be ... Documentation review including the generation, creation and review of all QA / production ...

The Jamar Company

QA/QC Supervisor

Duluth, MN · On-site

Maintain thorough inspection records, prepare quality reports, and document Non-Conformance Reports (NCRs) as required. * Participate in pre-job planning, QA/QC meetings, and audits to support ...

Reyes Holdings | Our Culture

QC/QA Supervisor

Eagan, MN

$75K - $94K/yr

The QA/QC Supervisor maintains corporate and franchise partner standards as well as environmental ... Associate's Degree with 4 plus years of related experience and 0 to 1 plus years of supervisory ...

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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 Minnesota are hiring for Quality Assurance Document Control Associate jobs? Cities in Minnesota with the most Quality Assurance Document Control Associate job openings:
Quality Assurance Document Control Associate jobs near you
Quality Documentation Control Specialist

Quality Documentation Control Specialist

PROMED MOLDED PRODUCTS INC

Minneapolis, MN • On-site

$29.68 - $40.96/hr

Full-time

Re-posted 18 days ago

Job description

POSITION SUMMARY

The Quality Assurance Document Control Specialist is responsible for day-to-day administration, maintenance, and continuous improvement of the organization’s document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment. Ensuring that QMS components are accurate, current, revised, approved, accessible and archived in a compliant manner. The Quality Documentation Control Specialist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.


ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:


  • Administer the operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records);
  • Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version;
  • Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use;
  • Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs);
  • Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements;
  • Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards;
  • Oversee the creation, review, approval and distribution of controlled documents, including SOPs, policies, forms and work instructions with ALCOA principles;
  • Maintains the documentation files in compliance with ISO 13485. FDA 21 CFR 820
  • and 21 CFR Part 11;
  • Manage electronic and physical document repositories;
  • Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion;
  • Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner as applicable;
  • Inputs data to create and revise material and method masters in the ERP system.

OTHER RESPONSIBILITIES

  • Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager;
  • Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities;
  • Support the implementation of regulatory changes and quality system improvements as directed;
  • Assist in preparing responses to audit observations or regulatory findings that involve document or records management.


QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Required:

  • Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field;
  • 0-2 years of experience in a regulated industry (pharma, biotech, or medical device);
  • Working knowledge of GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820);
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Preferred:

  • Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile) even if primary system is paper-based;
  • Experience with ISO 13485 quality management principles;
  • Knowledge of ALCOA+ data integrity principles;
  • Ability to work autonomously, effectively manage time and deliver results on time;
  • Attention to detail and commitment to data integrity and accuracy in all quality records;
  • Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations;
  • Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously;
  • Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions;
  • Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements;
  • Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items;
  • Aptitude for learning and applying regulatory requirements and quality standards.


WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job:

  • Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
  • Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
  • The noise level in the work environment is usually minor;
  • Duties are performed indoors;
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

  • The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
  • Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
  • The position requires the individual to meet multiple demands from several people and interact with internal and external people;
  • Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
  • Employee may have duties involving walking on even or uneven surfaces;
  • Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
  • Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
  • It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently;
  • Employee must see and hear on a continuous basis as well as speak frequently;
  • Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

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