QA Specialist II (2nd Shift)

About the role

Reports to the Manager Plant Quality. This is a full‑time, on‑site position located in Lititz, Pennsylvania, United States, working the 2nd shift as a QA Specialist II.

Kenvue realizes the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, the company owns iconic brands such as NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND‑AID®. With a global team of approximately 22,000 people, Kenvue’s culture values every voice, encourages insight‑driven innovation, and focuses on delivering the best products to customers worldwide.

Responsibilities

• Perform product release on 2nd shift after completing record review and ensuring non‑conformance investigations, laboratory investigations, and quality systems comply with GMP, GLP, local regulations, and company procedures.
• Provide QA support to operations.
• Work with a highly engaged team to perform quality review of production records, including manufacturing, packaging, and laboratory documents.
• Release finished product based on conformance to established standards.
• Apply quality assurance processes, procedures, and activities.
• Conduct walkthroughs and assessments of GMP areas.
• Partner with Operations to address quality/compliance issues and drive improvements.
• Complete review of batch records for complaint investigations.
• Generate and distribute certificates of compliance to foreign affiliates.
• Review compliance records, specifications, procedures, and other documents as required.
• Exercise limited approval responsibilities.
• Identify and suggest improvements to quality and plant operations; participate in and lead process‑improvement teams as appropriate.
• Maintain ownership of applicable SOPs and train others on them.
• Write and assist others in writing new or updated operating procedures.
• Conduct low‑risk/low‑complexity investigations and rationales focused on technical accuracy and regulatory compliance for quality documentation, including non‑conformances, corrective actions, CAPAs, audit observations, quality reports, and metrics.
• Provide independent recommendations to the Supervisor regarding compliance decisions with moderate business impact.
• Prioritize a highly complex and diverse workload under manager oversight, ensuring timely, accurate results.
• Assist in document preparation/presentation for regulatory agency visits and corporate/internal audits.
• Attend GMP training as scheduled and adhere strictly to applicable procedures.
• Identify, report, and seek correction for deviations promptly.
• Demonstrate integrity, employee involvement, and a commitment to doing the job right the first time.

Requirements

• Bachelor’s degree (minimum).
• At least 2 years of GMP experience in pharmaceutical, medical device, OTC drug, cosmetic, or food/dietary supplements production.
• Basic working knowledge of cGMP requirements and current FDA enforcement issues.
• Effective verbal and written communication skills.

Preferred qualifications

• Proficiency in office productivity software, with advanced skills in Microsoft Word and Excel.
• Strong analytical skills to develop actionable quality strategies and ensure regulatory compliance.
• Ability to work independently and influence cross‑functional teams without direct authority.

Pay

Annual base salary for new hires ranges from $72,675.00 to $102,600.00, depending on work location, candidate’s skills, experience, education level, and other job‑related factors.

Benefits

• Competitive benefit package.
• Paid company holidays.
• Paid vacation.
• Volunteer time.
• Learning & development opportunities.
• Kenvuer Impact Networks.