QA Specialist II (2nd Shift)

QA Specialist II (2nd Shift)

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Manager Plant Quality

Location:

North America, United States, Pennsylvania, Lititz

Work Location:

Fully Onsite

What you will do

Performs product release on 2nd shift after completing record review and assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures.  Provides QA support to operations.  

Key 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.
• 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.
• Generate, identify and suggest improvements as well as improvements to quality and plant operations. 
• Participate in and lead process improvement teams as appropriate.
• Maintain ownership and train others on applicable SOP’s. Write and assist others is writing new or updated operating procedures.
• Conduct low risk/low complexity investigations and rationales which are technically accurate and regulatory compliance focused for all quality documentation including non-conformances, corrective actions, CAPAs and audit observation responses, quality reports, metrics.  QA management will provide support.
• Independent recommendations to Supervisor regarding compliance decisions with moderate potential impact to business.
• With oversight from manager, prioritize highly complex and diverse workload ensuring results are timely, accurate, and meet their intended objective.
• Assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits.

Ensure quality and compliance in all my actions by:

All employees

• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Adhere to strict compliance with procedures applicable to my role.

• Exercise the highest level of integrity in the tasks that I perform.

• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time.

What we are looking for

Required Qualifications

• A minimum of a Bachelors Degree
• 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.
• Ability to communicate thoughts and ideas effectively – verbal and written.
• Demonstrated ability to accomplish work goals

Preferred Qualifications:

• 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

#LI-SR1

What’s in it for you

$72,675.00 - $102,600.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.