Document Control Specialist

Actalent; United States; Teletrabalho; USD 39 000 - 47 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Remote work options

Resumo da oferta

Actalent is seeking a Document Control Specialist to administer and maintain the document control system, ensuring controlled documents, records, and quality system documentation are reviewed, approved, distributed, revised, archived, and retained in alignment with FDA 21 CFR Part 820, QSR, ISO standards and MDSAP.

This fully remote contract role based out of Largo, FL requires an Associate's degree (Bachelor's preferred) and 2+ years in document control within a regulated industry, with

Qualificações

• Associate degree or higher in a relevant field with exposure to regulated environments.
• Minimum 2 years in document control within a regulated industry.
• Experience in medical device, pharmaceutical, biotechnology, or healthcare is preferred.
• Knowledge of FDA 21 CFR Part 820, QSR, ISO, MDSAP and GDP.
• Hands-on experience with electronic document management systems (eDMS).
• Proficiency in Word, Excel, PowerPoint, Outlook.
• Strong organizational skills and meticulous attention to detail.
• Excellent written and verbal communication abilities.
• Ability to manage multiple priorities and meet deadlines.
• Maintain confidentiality and data integrity in documentation.

Responsabilidades

• Manage the complete document lifecycle: creation, review, approval, distribution, revision, obsolescence, archival.
• Maintain electronic and paper-based document control systems for accuracy and access.
• Process ECOs, DCOs, and related documentation updates in a compliant manner.
• Route and secure approvals for SOPs, WI, Forms, Specifications, DMRs and other records.
• Maintain revision histories and document traceability per quality system requirements.
• Support compliance with QSR, ISO, MDSAP and regulatory requirements.
• Perform periodic audits of controlled documentation for accuracy and compliance.
• Coordinate document issuance and training related to new or revised procedures.
• Maintain retention and archival processes per policies and regulations.
• Assist with audits by providing requested documentation and evidence.
• Support CAPA, NCR, Risk Management files and related records.
• Track and report document control metrics to support continuous improvement.
• Collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations.
• Ensure templates, numbering, and formatting standards are consistently applied.
• Participate in continuous improvement initiatives for documentation processes.
• Perform data entry and quality control checks on documentation.

Conhecimentos

Document control

Records management

Regulatory compliance

Attention to detail

Communication skills

Time management

Confidentiality

Quality documentation

GDP knowledge

Formação académica

Associate's degree in Business Administration, Life Sciences, Engineering, Quality, or related field

Bachelor's degree preferred in Business Administration, Life Sciences, Engineering, or related discipline

Ferramentas

MasterControl

ETQ

Veeva

Arena

Microsoft Office Suite

Descrição da oferta de emprego

Job Title: Document Control SpecialistJob Description

The Document Control Specialist administers and maintains the organizations document control system to ensure full compliance with medical device regulations and quality management system requirements. In this role, you ensure that controlled documents, records, and quality system documentation are accurately reviewed, approved, distributed, revised, archived, and retained in alignment with company procedures and regulatory standards, including FDA 21 CFR Part 820, FDA Quality System Regulations (QSR), ISO standards, MDSAP, and other applicable global regulations. This position offers the opportunity to support a growing product line and gain valuable experience in the medical device industry.

Responsibilities

• Manage the complete document lifecycle, including creation, review, approval, distribution, revision, obsolescence, and archival of controlled documents.

• Maintain both electronic and paper-based document control systems, ensuring document accuracy, completeness, and ease of accessibility.

• Process Engineering Change Orders (ECOs), Document Change Orders (DCOs), and related documentation updates in a timely and compliant manner.

• Route and secure approvals for Standard Operating Procedures (SOPs), Work Instructions, Forms, Specifications, Device Master Records (DMRs), and other quality records.

• Maintain detailed revision histories and document traceability in accordance with quality system requirements.

• Support compliance with FDA Quality System Regulations (QSR), ISO standards, MDSAP, and other applicable regulatory requirements.

• Perform periodic audits of controlled documentation to verify accuracy, completeness, and regulatory compliance.

• Coordinate document issuance and assign training related to new or revised procedures to ensure appropriate awareness and implementation.

• Maintain records retention and archival processes in line with company policies and regulatory requirements.

• Assist with internal, customer, and regulatory audits by providing requested documentation, records, and evidence of compliance.

• Support Corrective and Preventive Actions (CAPA), Nonconformance Reports (NCR), Risk Management files, and other quality system records through accurate documentation management.

• Track and report document control metrics, including approval cycle times, overdue reviews, and current document status, to support continuous improvement.

• Collaborate closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations teams to ensure documentation accurately reflects current processes and practices.

• Ensure document templates, numbering systems, and formatting standards are consistently applied across all controlled documents.

• Participate in continuous improvement initiatives focused on enhancing quality system documentation and document management processes.

• Perform data entry and quality control checks on documentation to maintain high standards of accuracy and integrity.

Essential Skills

• Associate's degree in Business Administration, Life Sciences, Engineering, Quality, or a related field; a Bachelor's degree is preferred.

• Minimum of 2 years of document control experience in a regulated industry.

• Experience in the medical device, pharmaceutical, biotechnology, or healthcare industry is strongly preferred.

• Knowledge of FDA 21 CFR Part 820, FDA Quality System Regulations (QSR), ISO standards, MDSAP, and Good Documentation Practices (GDP).

• Hands-on experience with Electronic Document Management Systems (eDMS), such as MasterControl, ETQ, Veeva, Arena, or similar platforms.

• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.

• Strong organizational skills with exceptional attention to detail and accuracy.

• Excellent written and verbal communication skills, with the ability to clearly convey information to diverse stakeholders.

• Ability to manage multiple priorities and meet deadlines in a fast-paced, dynamic environment.

• Thorough understanding of document control principles and records management.

• Ability to maintain confidentiality and protect data integrity in all documentation activities.

• High level of accuracy and a strong commitment to quality in daily work.

• Experience with quality control and data entry in a regulated setting.

Additional Skills & Qualifications

• Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or a related discipline.

• Experience supporting FDA inspections, ISO audits, or MDSAP audits.

• Working knowledge of change control processes, CAPA, risk management, and broader quality system processes.

• ASQ certifications or other quality-related certifications are a plus.

• Familiarity with medical device quality systems and global regulatory frameworks.

• Strong analytical and problem-solving skills, with the ability to identify issues and propose effective solutions.

• Customer service orientation and the ability to work collaboratively and cross-functionally with diverse teams.

• Interest in contributing to a growing product line and gaining deeper experience in the medical device industry.

Work Environment

This role is fully remote, providing flexibility in work location while supporting teams across Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations. You will primarily work within electronic document management systems such as MasterControl, ETQ, Veeva, Arena, or similar platforms, along with standard office productivity tools including Microsoft Word, Excel, PowerPoint, and Outlook. The environment is fast-paced and quality-focused, with an emphasis on accuracy, compliance, and collaboration. Dress code is typical professional attire suitable for remote meetings and interactions.

Job Type & Location

This is a Contract position based out of Largo, FL.

Pay and Benefits

The pay range for this position is $28.00 - $34.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.