QA Investigations / Technical Writer

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

KVK Tech is seeking an experienced QA Investigations / Technical Writer to join our team in Newtown, PA. The QA Investigations / Technical Writer supports site quality systems by investigating quality events and developing, reviewing, and maintaining controlled documentation within an oral solid dosage manufacturing environment. This role ensures deviations, investigations, and quality documentation are accurate, compliant, and aligned with cGMP and regulatory requirements. The ideal candidate demonstrates strong technical writing skills, experience owning deviations and CAPAs, and the ability to collaborate cross‑functionally to support compliant manufacturing and continuous improvement.

Responsibilities

• Investigate and document quality events including deviations, incidents, planned deviations, OOS investigations, and customer complaints.
• Perform and document root cause analyses and develop appropriate corrective and preventive actions (CAPAs) in alignment with regulatory expectations.
• Draft, revise, and maintain controlled documentation such as SOPs, batch records, qualification and validation protocols, technical reports, and risk assessments.
• Support change control activities related to manufacturing processes, equipment, facilities, and quality systems.
• Collaborate with Manufacturing, Packaging, Engineering, and Quality teams to ensure documentation accuracy and procedural alignment.
• Support continuous improvement initiatives through trend analysis, audit observations, chamadas, and quality system enhancements.

Qualifications

• Bachelor’s degree in a scientific or technical discipline (Chemistry, Biology, Pharmacy, or Engineering) required; Master’s degree preferred.
• Minimum 3–5+ years of experience in a pharmaceutical or regulated manufacturing environment.
• Demonstrated experience in technical writing, deviation and CAPA management, and change control systems.
• Working knowledge of cGMP requirements (21 CFR Parts 210/211) and FDA quality system expectations.
• Strong written communication, analytical, and organizational skills with a high attention to detail.

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.