Quality Assurance Associate

KVK Tech, Inc.; Newtown (PA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

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

Job summary

Quality Assurance Associates in Newtown, PA seeks a QA Associate to review analytical data for raw materials, in-process materials, finished products, and stability samples using HPLC/UPLC and MOAs. You will design and maintain quality systems, including Deviations, CAPA, and Change controls in line with cGMP and FDA requirements.

The role requires a Bachelor's degree in Chemistry or Pharmaceutical Science and 1 year of related experience; MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA

Qualifications

• Bachelor's degree in Chemistry or Pharmaceutical Science required.
• 1 year of experience in quality assurance or related field required.
• Experience with MOA, Change Control, OOS/OOT, BMRs, APQR, and CAPA preferred.

Responsibilities

• Review and verify analytical data for raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and MOAs.
• Develop and maintain quality system elements including Deviations, CAPA management, and Change controls in compliance with cGMP and FDA.
• Prepare and initiate change controls to revise SOPs and related documents.
• Investigate reported OOS/OOT events.
• Review batch manufacturing records and support disposition activities.
• Prepare APQRs and track QMS metrics for management review.

Skills

MOA

Change Control

OOS/OOT

BMRs

APQR

CAPA

Education

Bachelor's degree in Chemistry or Pharmaceutical Science

Job description

October 28th, 2026

Quality Assurance Associates (Newtown, PA) - Review and verify the analytical data for Raw materials, in-process materials, finished products and stability samples using HPLC/UPLC and approved Method of Analysis (MOAs); Analyze, design, and develop quality system elements including Deviations, CAPA management systems and Change controls in compliance with cGMP and FDA; Prepare and initiate change controls to revise the SOP's; Conduct the investigations for reported Out-of-Specification (OOS)/Out-of-Trend (OOT); Review batch manufacturing records (BMR's) and support disposition activities; Prepare Annual Product Quality Reviews (APQRs) and QMS metrics for management review and maintain laboratory instruments in compliance with cGMP/cGLP and applicable FDA requirements.

Must have a Bachelor's degree in Chemistry or Pharmaceutical Science plus 1 year experience in job offered. Require skills and knowledge of MOA, Change Control, OOS/OOT, batch manufacturing records/BMRs, APQR, CAPA.

Job location: Newtown, PA.

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