2nd Shift QA Specialist II - GMP Release Expert

Kenvue Inc.

Lititz (Lancaster County)

On-site

USD 73,000 - 103,000

Full time

5 days ago

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Benefits offered by this job

Compensation package

Paid holidays & vacation

Volunteer time

Learning & development

Kenvue Impact Networks

Job summary

Kenvue Inc. in Lititz, PA is seeking a QA Specialist II on the 2nd shift to lead product release activities and ensure GMP/GxP compliance across manufacturing, packaging, and laboratory documentation.

You will partner with Operations, perform batch record reviews, and drive CAPAs and process improvements, while training others on SOPs and supporting regulatory audits. This role requires a Bachelor's degree and GMP experience in pharma/medical devices, with strong communication and analytical

Qualifications

A minimum of a Bachelor's Degree.
Minimum 2 years GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
Basic working knowledge of cGMP requirements and current FDA enforcement issues.
Ability to communicate thoughts and ideas effectively – verbal and written.
Demonstrated ability to accomplish work goals.

Responsibilities

Work with highly engaged and effective team.
Perform quality review of production records including manufacturing, packaging, and laboratory documents.
Responsible for releases of 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 improvements.