QA Associate I
About Us
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.
Our global team of ~22,000 brilliant people fosters 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.
About the Role
The QA Associate I – Plant Quality Operations is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. The primary responsibility for this role is Batch Records Review and Product Release. Additional QA support areas include Shop Floor, Standard Operating Procedures, Investigations, CAPA, Change Control, and Shop Floor Walkthroughs.
This position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance, and other departments as it relates to site Quality Assurance responsibilities. The role ensures compliance with company policies, procedures, and quality standards, as well as safety and environmental regulations, and provides daily support to product review and release functions.
Responsibilities
- Performs or supports activities related to Batch Record Review and Disposition of Raw Material, Bulk, and Finished Product.
- Performs or supports activities related to SUI Authorization, Reconciliation, and Shipping Order Processing.
- Performs or supports activities related to Material Reconciliation, Material Holds, DO Processing, and X-Batch Creation.
- Performs or supports activities related to APR Contributions for Raw Materials and Finished Goods.
- Performs or supports activities related to cMAT and sMIC creation and workflows.
- Performs or supports activities related to Maximo QARR Approvals.
- Performs or supports activities related to the design of quality processes and creation/modification/approval of Standard Operating Procedures (SOPs).
- Provides support to capturing site metrics and promotes improvement opportunities.
- Facilitates resolution of issues to improve site metrics.
- Provides training and direction as needed to new employees.
- Teams with department members for process feedback and continuous improvement opportunities.
- Performs or supports Shop Floor activities related to Equipment Status Updates, GMP Walk Throughs, Material Issuance, and Line or Area Cleaning Verifications as needed.
- Provides support to QA Shop Floor including responding to quality events and escalation to management as needed.
- Provides QA support to various project teams, as needed.
- Represents Quality Assurance in a positive manner.
Requirements
- Bachelor's degree in a relevant field or equivalent qualification in Engineering, Science, or a related field.
- 0-2 years of Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement within manufacturing or plant operations.
- Experience working effectively in a team-based environment.
- Strong organizational skills.
- Strong communication/interpersonal and facilitation skills (verbal, written, and presentation).
- Expertise in handling multiple priorities.
- Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint).
Qualifications (Preferred)
- 2 years of professional experience in a regulated industry.
- Process and Systems Experience, especially with SOPs, MBRs, Change Controls, and Non-Conformance Investigation Documentation.
- Experience with Liquid Dose processing and packaging technology preferred.
- Familiarity with quality systems, regulations, and business impact.
- Experience with LIMS, SAP, and EtQ is preferred.
- Experience with GMP.
Schedule
12-hour rotating workweek, structured around combinations such as two days on/two days off and three days on/three days off. 100% onsite, every scheduled workday.
Pay
Annual base salary for new hires in this position ranges: $61,880.00 - $87,360.00. This takes into account a number of factors including work location, the candidate’s skills, experience, education level, and other job-related factors.
Benefits
- Competitive benefit package.
- Paid company holidays, paid vacation, and volunteer time.
- Learning & development opportunities.
- Kenvuer Impact Networks.
Note: Total Rewards at Kenvue include salary, bonus (if applicable), and benefits. The specific salary range for the relevant location(s) will be shared during the recruitment and hiring process.