QA Associate Specialist – Document Control

Overview

Handle cGMP document control: receive, scan, archive, and retrieve records.

Key Responsibilities

• document archiving
• controlled docs
• insurance management
• audit support
• sop compliance
• file retrieval

Tasks

-Assist with Document Center Archive room activities. -Execute processes for identifying, collecting, distributing, and filing controlled documents. -Manage insurance and reconciliation of controlled forms and logbooks. -Organize cGXP controlled document files within the Document Center; ensure records are retrievable and archived as needed. -Support internal/external audits and regulatory inspections, including document retrieval and auditor escorting. -Follow SOPs and work instructions for document approval, effective dates, training workflows, and archiving.

Requirements

• fda/ema
• cgmp
• ms office
• part 11
• bachelors
• document control

What You Bring

-Familiarity with FDA/EMA regulations in biopharmaceutical or cell therapy manufacturing. -Excellent communication and customer service skills. -Strong knowledge of cGMPs and domestic regulatory requirements. -High school diploma/associate degree with equivalent experience considered. -Proficiency in MS Office (Word, Excel, Visio, Adobe) and Quality Systems (Document Management System, Quality Management System). -Minimum 3 years in document control/records management within a cGMP/FDA-regulated environment. -Experience with Part 11 compliance for scanning and electronic archiving. -Bachelor’s degree preferred (Library Science a plus). -Ability to prioritize, multitask, and troubleshoot in a fast-paced environment.

People Also Searched For

Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms