QA Associate II-Plant Quality Operations, Day Shift

QA Associate II-Plant Quality Operations, Day Shift

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

Supervisor 1, Quality Assurance

位置：

North America, United States, Pennsylvania, Fort Washington

工作地點：

完全現場

你會做什麼

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

對您有什麼好處

$72,675.00 - $102,600.00

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。