Administrative Laboratory Employee
il y a 1 semaine
We're searching for an exempt level position working within Technical Operations team, responsible for the batch record review of a personalized cell therapy to support both clinical and commercial requirements in a sterile environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule. You will work in a detail-oriented compliant manner.
Major Responsibilities
- Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports
- Assist in the correction of deficiencies found within the documentation reviewed on daily basis
- Ensure documents like batch records, labels, forms, etc. are printed and available for production.
- Perform First Quality review within Operations for executed batch records daily.
- Check completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch release.
- Perform other assigned duties as may be required in meeting company objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
- Gather production information to support the processes.
- Review of specific in-process, and finished product data.
- Document retrieval from local files and archives, as required for submissions and customer requests.
- Assist in process audits and internal audits as needed.
- Report/support Error Weekly Metrics (Right the First Time) Error Free, and success Rate found during review to Management.
- Works closely with QA functional 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 cycle time.
- Navigate through various online platforms.
- Initiate product non-conformance investigations and deviation investigations in COMET as necessary.
- Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issue.
Education:
- Bachelor's or Master's degree
Experience:
- A minimum of 1 year within a cGMP or ATMP environment in the biotech/biopharma industry is preferred but necessary.
- Knowledge of GMP is preferred but not necessary.
Capabilities, Knowledge, and skills:
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Well-developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Strong analytical, problem solving, pragmatic and positive critical thinking skills.
- Can do attitude, Right first time and Hands-on approach.
- Tenacity to drive issues until resolved and deliver results.
- Self-motivated, enthusiastic personality, team player.
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes.
- Desire to learn new skills and train juniors.
- Clear and succinct verbal and written communication skills.
- Excellent communication and organizational behaviors skills are required.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
- Ability to accommodate shift work including evenings and weekends as required by the process.
- Ability to accommodate unplanned overtime on little to no prior notice.
- A meaningful job , close to your home , with a very nice work-life balance . You work 4 days, then you have 4 days off .
- At Legend Biotech, you find more than a career. We offer you a path to growth, learning and personal development in an innovative environment, surrounded by colleagues you can really count on.
- Enjoy the opportunity to work with people from all over the globe. We are fully committed to diversity and inclusion and value every voice.
- The opportunity to volunteer for numerous projects and charities , allowing you to develop new skills.
- An indefinite contract and an attractive salary complemented by a comprehensive package of fringe benefits such as additional legal vacation days, meal vouchers, group and hospitalization insurance. And as icing on the cake, you'll also receive annually double vacation pay, an end of year bonus and a performance bonus.
- A l ot of fun and informal events.
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