Job#: 3037529 Job Description: Position SummaryThe 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
QualificationsEducation- 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)
Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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