Hiring: QA Specialist II (2nd Shift) Company: Kenvue Location: Lititz, PA Job Posted Time: 2026-09-16 19:17:32 Employment Type: On-site Target Skills & Keywords : Regulatory Compliance About the job Experience: •2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production. Required Skills: •Interface directly with highly engaged and effective team. •Perform quality review of production records including manufacturing, packaging, and laboratory documents. •Lead and oversee releases of finished product based on conformance to established standards. •Conduct walkthroughs and assessments of GMP areas. •Partner with Operations to address quality/compliance issues and 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 by procedure. Limited approval responsibilities. Qualifications: •A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production. •Basic working knowledge of cGMP requirements and current FDA enforcement issues. •Demonstrated capacity to communicate thoughts and ideas effectively – verbal and written. •Demonstrated ability to accomplish work goals •Proficiency in office productivity software, including advanced skills in Word and Excel •Strong analytical skills to develop actionable quality strategies and ensure regulatory compliance •Demonstrated ability to work independently and influence cross-functional teams without direct authority •This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors. •Paid Company Holidays, Paid Vacation, Volunteer Time & More! •Learning & Development Opportunities Compensation: •A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!