Senior QA Associate - QMS & CAPA Specialist

KVK Tech, Inc.; Newtown (PA); On-site; USD 80,000 - 100,000; 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

A pharmaceutical company in Newtown, PA is looking for a Senior QA Associate to enhance quality systems and compliance. The role requires 5-8 years of QA experience, with a Bachelor's degree in a scientific field and expertise in deviation management. Responsibilities include managing investigations and coordinating audits. Strong technical writing and analytical skills are essential. The position offers a full-time role with competitive benefits including a 401(k) match and tuition reimbursement, contributing to a supportive work environment.

Qualifications

• 5–8 years of pharmaceutical QA experience, preferably in oral solid dosage manufacturing.
• Strong expertise in deviation investigations, CAPA management, change controls, and technical documentation.
• Advanced knowledge of cGMP, data integrity principles, and ICH guidelines.

Responsibilities

• Review, approve, and manage deviations, investigations, and CAPAs to ensure compliance.
• Conduct structured root-cause analyses and develop corrective actions.
• Provide QA support during internal audits and FDA inspections.

Skills

Deviation investigations

CAPA management

Technical documentation

Analytical skills

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

MasterControl

TrackWise

Veeva

Job description

A pharmaceutical company in Newtown, PA is looking for a Senior QA Associate to enhance quality systems and compliance. The role requires 5-8 years of QA experience, with a Bachelor's degree in a scientific field and expertise in deviation management. Responsibilities include managing investigations and coordinating audits. Strong technical writing and analytical skills are essential. The position offers a full-time role with competitive benefits including a 401(k) match and tuition reimbursement, contributing to a supportive work environment.