Overview
QC Documentation Associate Jobs in Newtown, PA at KVK Tech
KVK Tech is seeking a detail-oriented QC Documentation Associate to join our Quality Control (QC) Chemistry department in Newtown, PA.
The QC Documentation Associate will maintain accurate, complete, and compliant documentation throughout the QC data lifecycle. This role supports the creation, revision, versioning, and maintenance of analytical methods, product specifications, controlled spreadsheets, and Empower calculations. The ideal candidate will demonstrate exceptional attention to detail, an understanding of cGMP documentation requirements, and the ability to maintain inspection-ready records in accordance with ALCOA+ data integrity principles.
This position’s responsibilities will include, but not be limited to the following:
- Prepare, revise, and maintain analytical methods, test procedures, product specifications, and related records within controlled documentation systems.
- Track compendial updates from USP/NF, EP, and JP and support the timely implementation of required changes to impacted methods, specifications, documents, and systems.
- 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 ensure accuracy, traceability, and compliance with data integrity requirements.
- 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 maintain consistent documentation practices.
We are looking for applicants with:
- Associate’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline required; Bachelor’s degree preferred.
- 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.
- 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 methods and product specifications.
- Strong proficiency in Microsoft Word and Excel; experience with controlled spreadsheets, formula validation, or Empower calculations preferred.
- Exceptional attention to detail, organizational ability, and written and verbal communication skills, with the ability to manage multiple priorities and collaborate with laboratory and quality personnel.
What we offer:
- 401(k) with company match
- Health, vision, and dental Insurance
- Childcare expense reimbursement
- Tuition reimbursement
- Annual bonus eligibility
- Annual merit increases
- Paid Time Off and Flexible Holidays
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you.
Title: QC Documentation Associate
Company: KVK Tech
Location: Newtown, PA
Category:
