QA Investigations / Technical Writer (Pharma Experience Required)

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The QA Investigations / Technical Writer plays a critical role in supporting site quality systems through the investigation of quality events and the development, maintenance, and control of regulated documentation. This position partners closely with Manufacturing, Packaging, Engineering, and Quality teams to ensure deviations, investigations, and technical documentation are accurate, compliant, and aligned with cGMP and regulatory expectations.

Key Responsibilities

• Prepare, review, and finalize quality investigations, including deviations, incidents, planned deviations, OOS investigations, and customer complaints.
• Perform root cause analyses and document corrective and preventive actions (CAPAs) with clear scientific and regulatory justification.
• Draft, revise, and maintain controlled documentation such as SOPs, batch records, qualification and validation protocols, technical reports, and risk assessments.
• Support change control activities by preparing, reviewing, and tracking documentation related to facilities, equipment, and process changes.
• Coordinate cross-functionally with Manufacturing, Packaging, Engineering, and Quality to ensure documentation accuracy and procedural alignment.
• Verify SOP revision cycles, expiration dates, and training requirements, initiating updates as needed.
• Provide training support for newly issued or revised SOPs, CAPAs, and quality system updates.
• Support documentation databases, trackers, and reporting tools to ensure visibility and timely completion of deliverables.
• Contribute to continuous improvement initiatives driven by trends, audits, inspections, or quality data analysis.
• Assist with special projects and additional QA documentation activities as assigned by Quality leadership.

What We’re Looking For

Experience

• 3–5+ years of experience in a pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Demonstrated experience with technical writing, deviation and CAPA management, change control systems, and quality investigations.
• Working knowledge of cGMP requirements (21 CFR Parts 210/211), FDA guidance, and quality compliance standards.
• Experience with electronic quality management systems (e.g., TrackWise, MasterControl, or similar) strongly preferred.

Education

• Bachelor’s degree (B.S.) in a scientific or technical discipline such as Chemistry, Biology, Pharmacy, or Engineering required.
• Advanced degree (M.S. or equivalent) preferred.

Skills & Knowledge

• Excellent written and verbal communication skills with strong command of grammar, formatting, and technical clarity.
• High attention to detail with the ability to translate complex technical information into clear, compliant documentation.
• Strong analytical, organizational, and problem-solving skills with experience in root cause analysis.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and electronic documentation systems.
• Ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment.
• Strong interpersonal skills and the ability to collaborate effectively across departments.
• Working knowledge of cGMP, ICH, and FDA documentation standards.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (M-F 8:00 AM - 5:00 PM)