QA Associate I

QA Associate I

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Quality Assurance Supervisor, Day Shift

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

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.  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 0-2 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

·         2 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.

·         Experience with GMP.

Shift

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. 

#LI-ND1

それは何ですか

$61,880.00 - $87,360.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。