Production Document Specialist I
thorne · Summerville
Job description
About the role
Thorne is seeking a Production Document Specialist I to create, revise, and maintain controlled production documentation that ensures accuracy, consistency, and compliance across manufacturing processes. The role works closely with Production, Quality, Operations and other cross‑functional teams to keep documentation aligned with current Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
Key responsibilities
- Develop and maintain SOPs, work instructions, GMP forms and other controlled documents in collaboration with subject‑matter experts.
- Route documents through the Quality Management System, monitor approval workflows and ensure timely completion.
- Conduct periodic reviews of assigned controlled documents and coordinate updates with SMEs.
- Collaborate with Production, Quality, Engineering and other teams to verify documentation reflects current processes and regulatory requirements.
Required profile
- High school diploma or GED required; Associate’s or Bachelor’s degree in Technical Writing, Manufacturing, Quality, Life Sciences or related field preferred.
- 1‑3 years of experience in document control, technical writing, manufacturing support or a regulated environment.
- Experience working in FDA, ISO or cGMP‑regulated settings is preferred.
Required skills
- Proficiency with Microsoft Word, Excel and Outlook.
- Experience using electronic Quality Management Systems (eQMS) or document management workflows.
- Working knowledge of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
What we offer
- Competitive compensation and 100% company‑paid medical, dental and vision insurance.
- Company‑paid short‑ and long‑term disability, life insurance and 401k matching up to 4%.
- Gym membership reimbursement, monthly allowance of Thorne supplements and paid time off.
- Training, professional development and career growth opportunities.
Questions fréquentes
Why are you reporting this job?
Explore further
Salaries, guides and searches in the United States.
Salaries by job title
Apply in 30 seconds
Enter your email to apply. An account will be created automatically.
By continuing, you accept our terms of use.
Already have an account? Login
Published 3 days ago
Expires 1 month from now
7 views · 0 interested
Boost your chances
Upload your CV — we will match you with relevant openings.
Analyzing your CV...
thorne
Summerville
Related job offers
-
Production Material Handler
thorne Summerville -
Maintenance Mechanic – Overnight Shift
thorne Summerville -
NDT Technician – Digital X‑Ray
NDT.org -
Automotive Diesel Specialist – Service Technician
Mills Automotive Group Diesel Village -
Pump Maintenance Worker
Erie County Water Authority Autorité palestinienne