Documentation Associate, Manufacturing

Job Description

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 Documentation Associate serves as a key contributor to Manufacturing and Packaging operations by supporting documentation, compliance, and investigation activities within a cGMP-regulated environment. This role focuses on technical writing, deviation support, and process documentation to ensure accurate, complete, and inspection-ready records. The Manufacturing Associate collaborates cross-functionally with Operations, Quality, and Engineering teams to support investigations, maintain controlled documentation, and drive continuous improvement initiatives.

Key Responsibilities:

• Support deviation investigations by reviewing production records, gathering information, and assisting in root cause analysis and CAPA development.
• Draft, revise, and maintain SOPs, forms, batch records, and other GMP documentation in compliance with internal standards and regulatory requirements.
• Assist with the initiation, review, and tracking of change controls related to manufacturing processes, equipment, and facilities.
• Maintain accurate and organized documentation in accordance with Good Documentation Practices (GDP) and ALCOA principles.
• Track and manage documentation, investigations, and project deliverables using spreadsheets, databases, and internal systems.
• Collaborate with Manufacturing, Packaging, Engineering, and Quality teams to support compliance initiatives and process improvements.
• Support qualification documentation and cross-functional projects as needed.

What We’re Looking For

Experience:

• 0–2 years of relevant experience in manufacturing, quality, compliance, technical writing, or a regulated environment preferred.
• Internship, co-op, or academic experience involving technical writing, data analysis, or documentation is a plus.
• Prior experience in a pharmaceutical or cGMP-regulated environment is preferred but not required.

Education:

• Bachelor’s degree from an accredited college or university strongly preferred .
• High school diploma or equivalent required.

Skills & Knowledge:

• Strong technical writing skills with excellent grammar, spelling, and attention to detail.
• Ability to analyze information, identify trends, and support problem-solving activities.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Effective communication and collaboration skills in a cross-functional team environment.
• Basic understanding of cGMP and documentation practices is preferred.
• High level of accuracy, accountability, and attention to detail in all work performed.

What We Offer

• Competitive 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)

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.

Company Description

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.