Technical Writer

Company: RCM Technologies (USA), Inc.
Location: Cranbury
Posted on: November 25, 2022

Job Description:

Job Title: Technical Writer

Job Function: Author, review and maintain documents for Quality Compliance

Job Type: Direct Hire

Location: On-site in Cranbury, NJ

About RCM:

RCM Life Sciences & IT is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

Scope of Job

RCM is seeking an entry level Technical Writer to join a growing CMO with the purpose of supporting Quality Compliance

Author, review and maintain documents (such as SOPS, Protocols, Work Instructions) covering Quality Event Records (including deviation, incident reports, planned deviation, Risk Assessments, CAPAs, Change Control Documents and Product Complaint Investigations.

Participate in the performance and documentation of investigations.

Prepare and review Out of Specification (OOS) investigations for internal and external analysis.

Prepare and review Master production and packaging batch records, qualification protocols and validation reports.

Collaborate with internal stakeholders and subject matter experts to define technical content.



Primary Responsibilities

Manage the routing, approval and administration of written standards in the controlled document repository systems.

Support the coordination, assignment and tracking of company technical training curricula.

Develop and maintain supplemental materials used to train on written standards.

Support the delivery and rollout of classroom training to staff.

Maintain and administer updates to other documentation used to demonstrate the safe and compliant facility and equipment operations such as risk assessments, statutory written schemes and manufacturer equipment manuals.

Maintain up to date knowledge of FDA regulations including 21CFR Part 210 & 211 and facility and engineering safety regulations.





Qualifications

Practical working knowledge of Pharmaceutical Manufacturing Operations

Ability to interpret complex data and draw valid conclusions

Continuous working knowledge of applicable cGMP guidelines and DEA regulations

Must understand how CAPAs and change controls must be incorporated into a document

2-4 years of experience working within a GMP environment

Excellent English writing, spelling, punctuation, and grammar skills with demonstrated document editing and proofreading experience.

Strong interpersonal skills and ability to effectively work and communicate with cross functional teams

Proficient in the use of spreadsheets, databases, presentation, and word processing software. Microsoft Office proficiency required

Education & Certifications

Bachelor 's degree or higher from an accredited college/university in a scientific discipline

Or at least 2-5 years of job related experience



Equal Opportunity Statement

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. 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.
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Keywords: RCM Technologies (USA), Inc., Trenton , Technical Writer, IT / Software / Systems , Cranbury, New Jersey