Quality Assurance Associate I

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：

QA Technical Lead

位置：

North America, United States, Pennsylvania, Fort Washington

工作地点：

完全现场

你会做什么

The position is responsible for providing daily 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 Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. 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.

As a QA Associate I, you will:

• Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.

• Provides leadership support to QA Shop Floor activities including communication of quality events to management.

• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.

• Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.

• Performs or supports activities related Line Audits, Line or Area Cleaning Verifications

• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).

• Provides support to Consumer Complaint investigations.

• Provide QA support to various project teams, as needed.

• Actively supports Site metrics, compliance improvement and training initiatives.

• Provide support to capturing of site metrics and promote improvement opportunities.

• Facilitate resolution of issues to improve site metrics.

• Represents Quality Assurance in positive manner

• Performs other related duties as required.

Qualifications

Required:

• Minimum of B.S. / B.A. Degree is required, a Science or technical field is preferred

• Minimum of 0-3 years of pharmaceutical industry quality experience, with shop floor experience

• Proven success in quality systems/compliance improvement

• Active cGMP interpretation and application experience

• Batch Record Review experience

• Problem solving/investigation experience

• Expertise in handling multiple priorities

• Strong organizational, communication/interpersonal and facilitation Skills (verbal, written and presentation)

• Requires up to 10% travel required based on business demands

• Ability to be based in Fort Washington, PA and requires up to ten percent (10%) of travel

• Ability to work (2) 12 hour shifts on weekend and (2) 8 hour shifts during the week

Preferred

• Process and Systems Experience, especially with MBRs, Change Controls, and Non-Conformance Investigation Documentation required

• Experience with Liquid Dose processing and packaging technology

对您有什么好处

$0,00 - $0,00

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。