QA Investigations & Technical Writer — cGMP Documentation Pro

KVK Tech, Inc.; Newtown (PA); On-site; USD 70,000 - 90,000; 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 manufacturing company located in Newtown, PA is seeking a QA Investigations / Technical Writer. This role involves investigating quality events and developing controlled documentation aligned with regulatory requirements. The ideal candidate should have strong technical writing skills and experience in deviation management. Key benefits include 401(k) with company match, health insurance, and tuition reimbursement. Join our team to support compliant manufacturing and continuous improvement.

Qualifications

• 3–5+ years of experience in a pharmaceutical or regulated manufacturing environment.
• Demonstrated experience in deviation and CAPA management.
• Working knowledge of cGMP requirements (21 CFR Parts 210/211) and FDA quality system expectations.

Responsibilities

• Investigate and document quality events including deviations and incidents.
• Draft, revise, and maintain controlled documentation such as SOPs and batch records.
• Support change control activities related to manufacturing processes.

Skills

Technical writing

Cross-functional collaboration

Root cause analysis

Change control management

Regulatory compliance

Education

Bachelor's degree in a scientific or technical discipline

Master's degree

Job description

A pharmaceutical manufacturing company located in Newtown, PA is seeking a QA Investigations / Technical Writer. This role involves investigating quality events and developing controlled documentation aligned with regulatory requirements. The ideal candidate should have strong technical writing skills and experience in deviation management. Key benefits include 401(k) with company match, health insurance, and tuition reimbursement. Join our team to support compliant manufacturing and continuous improvement.