KVK Tech, Inc.
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Documentation Associate
role at
KVK Tech, Inc.
KVK Tech is seeking a Documentation Associate to join our team in Newtown, PA.
The Documentation Associate will support Quality Control operations by maintaining accurate, complete, and compliant documentation across the analytical data lifecycle. This role ensures analytical methods, specifications, controlled spreadsheets, and Empower calculations are properly created, updated, versioned, and archived in accordance with cGMP and data integrity standards.
Responsibilities
Prepare, revise, and maintain analytical methods, test procedures, and specifications within controlled documentation systems.
Track compendial updates (USP/NF, EP, JP) and update impacted methods and specifications in accordance with regulatory timelines.
Process documentation change control requests, ensuring proper review, routing, and timely closure.
Validate, maintain, and monitor controlled Excel spreadsheets and Empower calculations to ensure compliance with ALCOA+ data integrity expectations.
Organize, file, label, and archive QC documentation (paper and electronic) in alignment with retention and SOP requirements.
Research technical or compendial information to support updates and provide documentation guidance to QC personnel.
Collaborate with QC analysts, supervisors, and QA reviewers to resolve documentation discrepancies and ensure consistent documentation practices.
Qualifications
Associate’s degree in a scientific discipline or related field required; Bachelor’s degree preferred.
1–2 years of experience in a GMP-regulated pharmaceutical environment, preferably within documentation control or QC.
Working knowledge of cGMP, GLP, FDA expectations, and data integrity principles (ALCOA+).
Strong proficiency in Microsoft Word and Excel, with familiarity in controlled spreadsheets and formula validation.
Excellent attention to detail, organization, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.
Benefits
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.
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Documentation Associate
role at
KVK Tech, Inc.
KVK Tech is seeking a Documentation Associate to join our team in Newtown, PA.
The Documentation Associate will support Quality Control operations by maintaining accurate, complete, and compliant documentation across the analytical data lifecycle. This role ensures analytical methods, specifications, controlled spreadsheets, and Empower calculations are properly created, updated, versioned, and archived in accordance with cGMP and data integrity standards.
Responsibilities
Prepare, revise, and maintain analytical methods, test procedures, and specifications within controlled documentation systems.
Track compendial updates (USP/NF, EP, JP) and update impacted methods and specifications in accordance with regulatory timelines.
Process documentation change control requests, ensuring proper review, routing, and timely closure.
Validate, maintain, and monitor controlled Excel spreadsheets and Empower calculations to ensure compliance with ALCOA+ data integrity expectations.
Organize, file, label, and archive QC documentation (paper and electronic) in alignment with retention and SOP requirements.
Research technical or compendial information to support updates and provide documentation guidance to QC personnel.
Collaborate with QC analysts, supervisors, and QA reviewers to resolve documentation discrepancies and ensure consistent documentation practices.
Qualifications
Associate’s degree in a scientific discipline or related field required; Bachelor’s degree preferred.
1–2 years of experience in a GMP-regulated pharmaceutical environment, preferably within documentation control or QC.
Working knowledge of cGMP, GLP, FDA expectations, and data integrity principles (ALCOA+).
Strong proficiency in Microsoft Word and Excel, with familiarity in controlled spreadsheets and formula validation.
Excellent attention to detail, organization, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.
Benefits
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.
#J-18808-Ljbffr