Document Associate Jobs in Pennsylvania (NOW HIRING)

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 QC Documentation Associate is a member of KVK Tech’s Quality Control (QC) Chemistry department and is responsible for maintaining accurate, complete, and compliant documentation throughout the QC data lifecycle. This role prepares and maintains analytical methods, test procedures, product specifications, controlled spreadsheets, and Empower calculations in accordance with cGMP requirements and ALCOA+ data integrity principles. The QC Documentation Associate also tracks compendial changes, processes documentation change requests, and works closely with QC and Quality Assurance personnel to maintain current, consistent, and audit-ready records.

Key Responsibilities:

• Prepare, revise, and maintain analytical methods, test procedures, product specifications, and related records within controlled documentation systems.
• Monitor compendial updates from USP/NF, EP, and JP, assess their potential impact, and support the timely implementation of required document and system changes.
• Process documentation change control requests, ensuring appropriate review, accurate routing, complete supporting information, and timely closure.
• Validate, maintain, and revalidate controlled Excel spreadsheets and Empower calculations to support accuracy, traceability, and data integrity.
• Organize, label, file, archive, and retrieve paper-based and electronic QC documentation in accordance with applicable SOPs and record-retention requirements.
• Collaborate with QC analysts, supervisors, and QA reviewers to resolve documentation issues, research technical or regulatory requirements, and promote consistent documentation practices.

What We’re Looking For

Experience:

• 0-3 years of experience in a GMP-regulated pharmaceutical environment preferred.
• Previous experience with QC documentation, document control, analytical method or specification management, controlled spreadsheets, Empower, or laboratory operations strongly preferred.

Education:

• Associate’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline required.
• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline preferred. A combination of relevant education and directly related pharmaceutical QC documentation experience may be considered.

Skills & Knowledge:

• Working knowledge of cGMP, GLP, FDA expectations, Good Documentation Practices, and ALCOA+ data integrity principles.
• Familiarity with compendial sources such as USP/NF, EP, and JP and an understanding of how compendial changes may affect analytical procedures and specifications.
• Strong proficiency in Microsoft Word and Excel; experience with controlled spreadsheets, formula validation, or Empower calculations preferred.
• Exceptional attention to detail and the ability to accurately review, track, organize, and maintain technical documentation.
• Strong written and verbal communication skills, with the ability to manage multiple priorities and collaborate effectively with laboratory and quality personnel.

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.