Analyst II, QC Data Services - Winnipeg - Emergent BioSolutions

Description

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Summary

The QC Data Services Analyst is responsible for supporting all activities associated with the Laboratory Information Management System (LIMS) for the Winnipeg Global LabVantage LIMS system. They will provide direct support to LIMS users for LIMS related requests such as user access, trouble shooting, master data requests, protocol creation, reporting and maintenance activities; as well as system administration to ensure cGMP compliance in the LIMS business processes. After-hours on-call availability is a requirement for this position. In addition, this position will provide data analysis for the QC department and other departments as requested.

Responsibilities

• Serve as site administrator and technical expert for the LabVantage LIMS to assist and provide support to new and existing end users at Emergent.
• Complete administration for user accounts.
• Perform transactional and master data changes as required.
• Build master data in LIMS system, execute testing and aid in migration through the LIMS environments.
• Provide support and maintenance, problem solving and information gathering for the LV LIMS system including after hours support.
• Train users in the LV LIMS system.
• Diagnose system problems and develop/coordinate resolutions with internal and/or external partners as needed.
• Work closely with applicable business units and users to generate user requirements and understand system functionality and use, as well as assist in implementation of new functionality.
• Assist with the validation of system improvements (drafting user requirements, UATs, PQ protocols, and execution of protocols).
• Be available to support LIMS users after-hours on a rotational basis.
• Provide trending support for various departments on LIMS data for investigations, deviations or change controls.

Provide basic support during regulatory inspections.

Participate in team projects (local and global).

Author and collaborate on SOPs, Deviations, CAPAs, and Change Controls as necessary.

The statements above describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

Education

• Bachelor's Degree in biological science or computer science required; or on a case-by-case basis, will consider a combination of education/training and relevant work experience.

Experience

• 2-4 years of experience within a cGMP/FDA/Biotechnological/Pharmaceutical laboratory setting environment.
• 2-4 year's experience as a LIMS user. Experience as a LIMS administrator is an asset.
• Experience in a pharmaceutical cGMP lab environment is an asset but is not required.

Skills

• Commitment to excellence.
• Ability to work in a high paced environment.
• Ability to adapt to change.
• Self-motivated, with excellent organizational skills and critical-thinking skills.
• Strong written and oral communication skills
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Strong analytical, troubleshooting, and problem-solving abilities
• Flexible and cooperative spirit with strong commitment to team efforts.
• Demonstrated ability to execute on complex procedures and problem solve.
• Able to provide training to peers in an effective manner.
• Basic knowledge in the use of Microsoft Office suite of products is required.
• Knowledge of JMP statistical software and Power BI is an asset.
• Ability to apply statistical analysis to QC monitoring and trending using statistical analysis tools such as control/capability charts, pivot tables, box-plot charts, pareto charts, histogram, and pie charts.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.