QA Monitor (3:00 pm - 11:30pm; Entry Level)

QA Monitor – KVK Tech

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to producing high-quality, FDA-approved medicines that improve patient access to affordable treatment. Located in Newtown, Pennsylvania, KVK Tech operates under the highest cGMP and regulatory standards, manufacturing all products domestically to ensure quality, consistency, and integrity. We are driven by our mission to combine technical excellence with ethical responsibility — ensuring that every product we make meets the highest standards of safety and efficacy.

What You’ll Do

The QA Monitor plays a critical role in maintaining cGMP compliance by overseeing cleaning, sanitation, and line clearance activities across manufacturing and packaging areas. This role ensures that equipment, utensils, and rooms are properly cleaned, labeled, and documented prior to use — helping prevent contamination, mix-ups, and other compliance risks.

Key Responsibilities:
• Visually verify equipment, utensils, and production areas for cleanliness and readiness prior to manufacturing operations.
• Observe and document cleaning and sanitation practices, ensuring adherence to approved procedures, detergents, and labeling standards.
• Review and verify cleaning logs, line clearance records, and housekeeping forms for accuracy, completeness, and compliance.
• Inspect and confirm proper use of “Cleaned” and “To Be Cleaned” tags on equipment and areas.
• Monitor line clearance activities to ensure removal of all previous materials, documents, and components prior to new batch startup.
• Document findings and escalate any nonconformance, residue, or deviation to QA management immediately.
• Support QA Inspectors and Production teams by maintaining a clean, organized, and inspection-ready work environment.
• Ensure all documentation meets ALCOA principles and is completed contemporaneously and accurately.
• Participate in internal audits, housekeeping walkthroughs, and process improvement initiatives related to cleaning verification.
• Perform other QA-related duties as assigned to support overall site compliance.

What We’re Looking For

Experience: 0–2 years of experience in a cGMP pharmaceutical, manufacturing, or other regulated production environment. Prior exposure to cleaning, sanitation, or QA monitoring activities in oral solid dosage manufacturing is preferred.

Education: High school diploma or equivalent required; Associate degree in Life Sciences or related technical discipline preferred.

Skills & Knowledge:
• Basic understanding of cGMP cleaning, sanitation, and line clearance requirements.
• Strong attention to visual detail and cleanliness verification.
• Ability to complete and review documentation accurately and legibly.
• Effective communication and observation skills for on-floor monitoring.
• Strong sense of accountability, reliability, and integrity.
• Proficiency with Microsoft Word, Excel, and Outlook for QA documentation.
• Flexibility to work varied shifts, weekends, or overtime as production demands require.

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 (3:00 pm-11:30 pm); flexibility for off-shift or weekend monitoring as needed)