Manufacturing Change Specialist Intern

American Regent•Shirley, NY

21d•$19 - $21•Onsite

About The Position

Nature and Scope The Manufacturing Change Specialist Intern provides support to Manufacturing Supervision/Management as needed and is critical in maintaining compliance expectations for Corrective and Preventative Actions (CAPAs), Protocols, Change Controls, Annual Product Reviews (APRs), SOPs, and Media Fills. The Manufacturing Change Specialist Intern will participate in all aspects of the Document and Change Control Process. This includes all elements of the document lifecycle such as creation, editing, and reviewing Standard Operating Procedures and Product Masters, as well as initiation and execution of change controls for respective controlled documents as per applicable Standard Operating Procedures. Ability to complete a 13-week program (from May 18, 2026 to August 14, 2026) and commit to 40 hours per week onsite in Shirley, NY. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Assist in the creation or revision of controlled documents including Standard Operating Procedures, specifications, protocols, product masters/modules, and other miscellaneous documents. Collaborate with department SMEs and incorporate applicable feedback into process and document changes. Assist in preparing controlled documents through the document and change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing. Assist in performing training impact assessments for document change controls by reviewing module assignments and revising applicable document assessments. Ensure Change Controls for the process and document related changes are completed or extended before the due date while working with the QA Change Control team. Maintain regular communication with impacted departments for scheduled document effectiveness and associated required training for effectiveness. Assist in the Media Fill execution by reviewing and compiling batch record data, etc. Provide support for manufacturing projects (i.e. capital expansion project). Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures. Perform tasks with a minimal error rate. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. 1+ years of college level courses pursuing a degree in Science , Technology, Engineering or Math is required.

Requirements

1+ years of college level courses pursuing a degree in Science , Technology, Engineering or Math is required.
Intermediate skills in Microsoft Word and Excel, required.
Excellent organizational, interpersonal and communication skills (written and oral), required.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Must be self-motivated with the ability to manage, organize, and prioritize multiple tasks to meet deadlines.
Ability to take feedback constructively and function in a team-oriented work environment.

Nice To Haves

Experience in editing controlled documents or relevant technical writing experience, preferred
Experience in a manufacturing environment or pharmaceutical manufacturing, preferred
Work experience in an FDA regulated environment, preferred

Responsibilities

Assist in the creation or revision of controlled documents including Standard Operating Procedures, specifications, protocols, product masters/modules, and other miscellaneous documents.
Collaborate with department SMEs and incorporate applicable feedback into process and document changes.
Assist in preparing controlled documents through the document and change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing.
Assist in performing training impact assessments for document change controls by reviewing module assignments and revising applicable document assessments.
Ensure Change Controls for the process and document related changes are completed or extended before the due date while working with the QA Change Control team.
Maintain regular communication with impacted departments for scheduled document effectiveness and associated required training for effectiveness.
Assist in the Media Fill execution by reviewing and compiling batch record data, etc.
Provide support for manufacturing projects (i.e. capital expansion project).
Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
Perform tasks with a minimal error rate.
Perform any other tasks/duties as assigned by management.