Job Information
RCM Technologies Documentation Specialist in United States
Full Time Contract Role: Documentation Specialist Location: Manati, PR 100% Onsite Length of Contract: 8+ Months Position Description:
The Documentation Specialist will support the C&Q Lead and Specialists by managing the end-to-end document lifecycle for the PUPSIT Skid Implementation . This role focuses on the rapid authoring of protocols (SLIA, CCA, DIRA) and the coordination of the approval workflow within the client Client ALM system. The goal is "Right-First-Time " (RFT) documentation to ensure the September 14th closeout is met.
Responsibilities:
GxP Authoring: Draft and format Commissioning and Qualification protocols (IQ/OQ) and reports using client-approved templates .
ALM Management: Upload, track, and route all project deliverables through the Client ALM (Quality Center) system for stakeholder approvals.
SOP Development: Author a unified operational Standard Operating Procedure (SOP) covering the PUPSIT process mechanics and software logic.
Audit Readiness: Ensure all documentation meets 21 CFR Part 11 and Data Integrity (DI) standards.
Quality Review: Perform "Pre-QA " checks on executed protocols to identify and correct GDP (Good Documentation Practice) errors before final routing.
Qualifications:
Experience: 2–4 years of technical writing or document control experience in an FDA-regulated (GxP) environment.
Mastery of MS Word (Styles, Tables, Headers/Footers) and Excel .
Proven experience with Client ALM , Kneat , or Documentum .
Understanding of Good Documentation Practices (GDP) .
Soft Skills: High attention to detail; ability to manage multiple deadlines in a fast-paced shutdown environment.
Education
B.A./B.S. in Technical Writing, English, Communications, or a Science-related field.
Equal Opportunity Employer: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. About RCM: RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.