QA Associate II-Plant Quality Operations, Day Shift

QA Associate II-Plant Quality Operations, Day Shift

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Supervisor 1, Quality Assurance

位置：

North America, United States, Pennsylvania, Fort Washington

工作地点：

完全现场

你会做什么

The QA Associate II – 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.  Primary responsibility for this role is Batch Records Review and Product Release. Additional QA support areas include but are not limited to Shop Floor, Standard Operating Procedures, Investigations, CAPA, Change Control, and  Shop Floor Walkthroughs. The 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.

Responsible for ensuring compliance with company policies, procedures, and quality standards, as well as safety and environmental regulations. Provides daily support to product review and release functions.  Writes and assists others in writing standard operating procedures.

Key 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 design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
• Provide support to capturing of site metrics and promote improvement opportunities.
• Facilitate 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.

Other Support Functions

• 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.
• Provide QA support to various project teams, as needed.
• Represents Quality Assurance in positive manner.

What we are looking for

Required Qualifications

• Bachelor's degree in a relevant field or equivalent qualification in Engineering, Science, or a related field.
• Requires 2-4 Years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement within manufacturing or plant operations.
• Experience with 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)

Desired Qualifications

• 4 years professional experience in a regulated industry
• Process and Systems Experience, especially with SOPs, MBRs, Change Controls, 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.

#LI-SR1

对您有什么好处

$72,675.00 - $102,600.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。