Document Control Associate AdministrativeClerical Position Job Newtown area,Pennsylvania USA,Quality Assurance

Job Description

About KVK Tech

KVK Tech is a U.S.

-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The Document Control Associate supports the Quality Management System by maintaining accurate, current, and controlled GMP documents and records. This role administers the formatting, issuance, retrieval, archival, and lifecycle control of SOPs, batch records, protocols, reports, controlled forms, and logbooks. The Document Control Associate works closely with Quality Assurance and cross-functional departments to ensure documentation is complete, readily retrievable, and maintained in compliance with cGMP, Good Documentation Practices, and data integrity requirements.

Key Responsibilities:

Administer document control activities for SOPs, batch records, protocols, reports, work instructions, controlled forms, and related GMP documents within Master Control or the applicable document management system.
Format and process new or revised controlled documents in accordance with approved templates, workflows, SOPs, and document control procedures.
Issue, retrieve, reconcile, file, archive, and maintain controlled batch records, protocols, forms, logbooks, and other GMP records.
Review submitted documents and executed records for completeness, legibility, required information, and proper document status before filing or archival.
Scan, index, and maintain organized physical and electronic document files to ensure accurate and timely record retrieval.
Maintain document control logs, tracking spreadsheets, and metrics while supporting document reviews, audits, regulatory inspections, and assigned Quality System activities.

What We're Looking For

Experience:

0–3 years of experience in document control, records management, quality assurance, data entry, or administrative support.
Experience in a pharmaceutical, biotechnology, or other cGMP-regulated manufacturing environment preferred.
Experience with an electronic document management system such as Master Control or an equivalent platform preferred.

Education:

High school diploma or equivalent required.
Associate degree in Science, Business, Records Management, Quality, or a related field preferred.

Skills & Knowledge:

Basic understanding of document control, cGMP, Good Documentation Practices, and data integrity principles, or the ability to learn these requirements.
Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
Strong attention to detail, accuracy, organization, and document-management skills.
Ability to perform accurate data entry, scanning, indexing, filing, and records-retrieval activities.
Effective written and verbal communication skills with the ability to manage multiple priorities and collaborate with cross-functional teams.

What We Offer

Competitive hourly compensation with annual performance bonus eligibility
Annual merit-based pay increases

Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
Paid Time Off
10 paid company holidays
Comprehensive medical, dental, vision, and life insurance coverage
Professional development reimbursement
Career growth opportunities
Tuition reimbursement for children and childcare expense reimbursement

Schedule

Full-time, on-site position (Monday–Friday, 8:00 AM–5:00 PM)

Company Description