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Standards Coordinator, Analytical Services
3 months ago
**_
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services.
It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies._**
_ In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories.
Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
__ In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years._
_ _________________________________
- Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its stateoftheart organization, with continued investments in its people, modern facilities, equipment, and instrumentation._
Job Description:
The Standards Coordinator, Analytical Services is accountable to the Senior Manager, Analytical Services/Senior Team Leader for all activities relating to the management of standards and reporting to the Senior Team Leader.
The scope of the responsibility includes independently planning and performing Standard qualifications/re-qualifications, guiding 2-3 staff to perform analytical standard qualification, quoting for standard qualification and management of standards inventory used across the organization.
Standard Coordinator, Analytical Services is an active member of interdepartmental research teams and is able to independently plan and carry out investigational work related to standards management and work with other staff to manage workload as required in a safe and effective manner.
The Standards Coordinator, is an active participant in the preparation and presentation of client updates, when required, and in communicating both internally and externally in a clear and efficient manner.
DUTIES AND RESPONSIBILITIES:
Core:
- Follow Environmental, Health and Safety rules/regulations and report any workplace injuries or accidents immediately.
- Adhere to the policies and guidelines set out in the Alphora Employee Handbook.
- Work harmoniously with all fellow employees.
- Responsible for compliance with GMP guidelines and ensuring that all GMPs and SOPs are followed.
- Exceptional communication skills both with external and internal clients.
- Independently plans and coordinates the execution of standard qualification and requalification activities in the analytical services laboratory according to required timelines.
- Performs or oversee standard qualifications testing. Provides support on standard qualification to 23 analytical chemists.
- Independently plans and executes the proper distribution of standards to clients and interdepartmental groups and oversees the maintenance of standard inventory. Manages resources with the team leader to support projects.
- Prepares analytical updates, if required on standard qualification activities related to the project for client review with support from the Team Leader.
- Author analytical test methods and specifications for cGMP use by either by QC or Analytical Development.
- Conduct peer review of analyses as required.
- Plan and prepare quotations related to standard requalification activities based on client needs and according to applicable Alphora SOP's.
- Work neatly to maintain the laboratory in an organized state.
- Assist in project planning and staff training.
Additional:
- Order laboratory supplies and chemicals as required.
- Perform additional duties as required.
COMMUNICATION AND CONTACTS:
Within the Company
- Quality Assurance for do
