QMS Document Writer

LanceSoft Inc

Richmond, VA

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JOB DETAILS

SALARY

$58.39–$58.39 Per Hour

SKILLS

American Society for Quality (ASQ), Analysis Skills, Biology, Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Data Quality, Detail Oriented, Document Change Management, Document Control, Document Management, Documentation, Documentation Review, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), ISO 9001, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Multitasking, Network Connectivity, Operational Support, Presentation/Verbal Skills, Problem Solving Skills, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Management, Requirements Validation/Verification, Standard Operating Procedures (SOP), Support Documentation, Technical Writing, Time Management, Writing Skills

LOCATION

Richmond, VA

POSTED

7 days ago

Shift: Monday-Friday, 1st shift hours
Duration: 06 Months
Pay range: $51.00 - $58.39/hr.
Onsite Job

Job Description:

Position Summary
The Technical Writer – Quality Management Systems (QMS) is responsible for developing and revising Quality controlled documentation that supports manufacturing operations and ensures compliance with applicable regulatory requirements, internal standards, and quality management system expectations. This role translates complex technical, regulatory, and operational requirements into clear, accurate, and inspection ready documents aligned with enterprise document control processes.
Key Responsibilities

QMS Documentation Development
Author, revise, and maintain controlled documents, including:
Standard Operating Procedures (SOPs)
Work Instructions
Forms and Templates
Master and Batch Manufacturing Records (MMR/BMR)
Ensure documents clearly define manufacturing processes, product requirements, and quality controls in alignment with QMS standards and regulatory expectations.
Regulatory & Compliance Alignment
Interpret and translate regulatory requirements (e.g., FDA, ISO, internal quality standards) into structured, compliant documentation
Ensure documentation supports audit readiness, traceability, and objective evidence requirements
Maintain consistency with enterprise quality requirements and governance frameworks
Cross Functional Collaboration
Partner with manufacturing, quality, engineering, and regulatory teams to gather requirements and validate content accuracy
Facilitate document reviews with subject matter experts (SMEs) to ensure technical and regulatory alignment
Incorporate feedback and drive timely document completion

Qualifications
Education

Bachelor’s degree in Technical Writing, Life Sciences, Engineering, or a related field (or equivalent experience)
Experience
5–8+ years of experience in technical writing within regulated manufacturing environments (e.g., pharmaceutical, tobacco, food, medical device)
Experience with Quality Management Systems (QMS) and document control processes
Familiarity with manufacturing documentation (e.g., SOPs, MMR/BMR, specifications)

Technical Skills

Strong understanding of:
Quality Management Systems (QMS) principles
Regulatory requirements (e.g., FDA, ISO 9001, GMP concepts)
Document control and change management processes
Ability to translate complex technical processes into clear, concise documentation
Core Competencies
Attention to detail and accuracy
Strong written and verbal communication skills
Analytical thinking and problem-solving
Ability to manage multiple priorities and deadlines
Collaboration and stakeholder engagement

Preferred Qualifications (Optional)

Experience supporting FDA inspections or regulatory submissions
Knowledge of data integrity and audit trail expectations
Certification in technical writing or quality systems (e.g., ASQ, CQIA)

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

Four options of medical Insurance
Dental and Vision Insurance
401k Contributions
Critical Illness Insurance
Voluntary Permanent Life Insurance
Accident Insurance
Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/