製造アナリスト兼ドキュメンテーションコーディネーター - Core 1
アナリスト契約社員全レベル · 2年以上Westport, MOハイブリッド
バッチ記録の流れを調整し、製造書類をレビューして規制遵守を確認します。CGMP、無菌操作、データ整合性、GDPに関する詳細な知識が必須です。関連分野の学士号が望ましく、類似職種での2年以上の経験が求められます。毎週火・水・木曜日はオフィス出社が必須で、月・金曜日はリモートワークが可能です。
バッチ記録の流れを調整し、製造書類をレビューして規制遵守を確認します。CGMP、無菌操作、データ整合性、GDPに関する詳細な知識が必須です。関連分野の学士号が望ましく、類似職種での2年以上の経験が求められます。毎週火・水・木曜日はオフィス出社が必須で、月・金曜日はリモートワークが可能です。
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Westport, MO
Function: Operations
Work location type: On-Site
Job Type Full-time
Job ID: R00147726
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
We are now recruiting an experienced Manufacturing Analyst and Documentation Coordinator to join our Core 1 Operations team in AbbVie Westport, Co Mayo on a fixed term contract.
In the role, you will have the opportunity to coordinate batch record flow, corrections, manufacturing status tracking spreadsheets, report preparation, Complaints tracking. The successful candidate will perform reviews of manufacturing and other paperwork to ensure compliance to Abbvie and regulatory standards. The manufacturing analyst will be required to communicate up to date status reviews and work with Manufacturing Technicians, Technical Writers and Technical Shift leads to coordinate and ensure the completion of manufacturing batch paperwork.
If great benefits, a defined career path, and work-life balance are important in your next career move, then read on to find out more:
Key activities:
Compile and perform manufacturing audit review of batch paperwork from manufacturing areas.
Ensure all batch records components are present and that all corrections identified during initial review and by Product Release Team are addressed in a timely and compliant manner.
Use and maintenance of data within key systems such as SAP, S4HANA.
Document retrieval from local files and archives, as required for submissions, customer requests and others.
Participate in non-conformance and exception investigations as necessary.
Work with QA Teams to align and promote awareness on data integrity and good documentation practices.
Facilitate and coordinate with project teams to enhance, improve and streamline batch records.
Management of purchasing requisitions.
Provide assistance when required at Regulatory Inspections.
Trending and c-ordination of customer complaints investigations.
Work close with Depts on corrective actions arising from Environmental excursions.
Comply with Abbvie policies and procedures and regulatory agency regulations.
Qualifications
Bachelor’s degree in science, or a related field is preferred and/or a minimum of 2 years’ experience in a similar role.
Detailed knowledge of CGMP and aseptic practices, data integrity requirements and GDP is required for this role.
Strong organizational skills and attention to detail are essential for this role.
Good interpersonal relations/communications skills
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Recruitment Fraud Alert
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If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.
Protect yourself by verifying job offers and communications. Your safety is important to us.
Pay Range: $
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.