QA Specialist II - 3rd Shift - Kenvue Brands LLC

Kenvue is currently recruiting for:

QA Specialist II-3rd Shift

This position reports to Manager Plant Quality and is based at Lititz, PA

Who we are

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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: Lititz PA

Travel %: 5, if any

What you will do

The QA Specialist II is responsible for Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Shop Floor Activities, Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control.

Key Responsibilities

• Work with highly engaged and effective team.
• Provides daily 'Shop Floor" QA support to bulk manufacturing, packaging lines and warehouse by coaching and providing guidance for quality related events.
• Conduct real time review of mixing and packaging documentation.
• Provides support to QA Shop Floor activities including communication of quality events to management.
• Apply quality assurance processes, procedures, and activities.
• Perform quality review of production records including manufacturing, packaging, and laboratory documents.
• Responsible for releases of finished product based on conformance to established standards.
• 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 inspections, responsibilities include conducting, writing, reviewing and approvals. QA management will provide support.
• Provides training and direction, as needed, to new employees.
• 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.
• Complete review of batch records for complaint investigations, as required.
• Generate and distribute certificates of compliance to foreign affiliates, as required.
• Will work 3 rd Shift-11pm-7:30am, training will be done on first shift

Required Qualifications

• Minimum of a Bachelor's degree in Arts/Science
• Minimum of 2 years 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
• Demonstrated leadership- possesses the ability to coach others
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Problem Solving/Investigation Experience
• Expertise in Handling Multiple Priorities

Desired Qualifications

• Some experience in a manufacturing environment is desired

What's in it for you

• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

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