Standards Coordinator, Analytical Services Eurofins Cdmo Alphora, Inc

Toronto, ON, Canada

Job Description


Company Description

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 \xe2\x82\xac 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 state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation.



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 re-qualification activities in the analytical services laboratory according to required timelines.
  • Independently plans and executes investigational work, generating reports subject to client and regulatory review.
  • Performs or oversee standard qualifications testing. Provides support on standard qualification to 2-3 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\xe2\x80\x99s .
  • 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 documentation approval and corrections (analyses, protocols, reports and instrumentation IQ/OQ/PV).
  • Active member of interdepartmental Process Research and Development teams for collaboration in analytical standard qualification and requalification.
  • Quality control for the transfer of standard and associated documentation.
  • Engineering for issues relating to facility support of instrumentation.
Outside of the Company
  • Interacts with clients and various contractors and suppliers of services and supplies / equipment.
Qualifications
  • Exceptional communication skills both written and verbal
  • Exceptional organization skills
  • Minimum 5 years experience in pharmaceutical organization with experience overseeing projects and staff
  • Minimum Educational requirement BSc
  • Proficient in Excel and Word.
Additional Information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at .

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

NO AGENCIES, CALLS OR EMAILS PLEASE

Eurofins

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Job Detail

  • Job Id
    JD2134913
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Toronto, ON, Canada
  • Education
    Not mentioned