Analyst II, QC Laboratory Services

Emergent BioSolutions; Winnipeg; On-site; CAD 50,000 - 70,000; Full time

Job summary

A biotechnology firm is seeking a qualified candidate in Winnipeg, Manitoba, to perform GMP compliant testing and maintain laboratory documentation. The role includes responsibilities such as supporting various testing processes, training junior staff, and adhering to GMP standards. A university degree in a related field and experience in a laboratory environment are essential. The candidate should excel in analytical skills and be proficient in Microsoft Office.

Benefits

Competitive salaries

Flexible work arrangements

Extensive benefits package

Qualifications

• Minimum two to four years of directly related experience in a recognized professional or technical/scientific field.
• Experience in a pharmaceutical cGMP environment is an asset but not required.
• Ability to work in a fast-paced and highly regulated environment.

Responsibilities

• Perform GMP compliant testing to support Raw Material testing, In-process, and Finished Product Release.
• Maintain laboratory documentation and perform preventative maintenance on equipment.
• Train and provide assistance to junior staff.

Skills

Analytical skills

Communication skills

Organizational skills

Microsoft Office proficiency

Education

University degree or technical diploma in chemistry, biology, microbiology, or related field

Tools

LIMS

Microsoft Office

Job 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.

Job Summary

Perform GMP compliant testing as required to support Raw Material testing, In-process, FinishedProduct Release & Stability, nonclinical / clinical studies, as well as assay or process validations.

Maintain laboratory documentation and perform preventative maintenance and calibration on laboratory equipment per established procedures.

Contribute to and author investigations, deviations, critical reagent and standard qualifications,validation/verification protocols and reports, supplier qualifications, CAPAs and change controls.

Train and provide assistance to junior staff; provide training to peers/junior staff in an effectivemanner.

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities toperform the essential functions.

· Receive test samples, standards, chemicals, and reagents; maintain accurate laboratoryrecords and inventory for all laboratory materials.

· Demonstrate proficiency when performing analytical test methods with minimal supervisoryguidance.

· Be proficient in a variety of analytical/biological/Compendia methodologies and techniques.

· Report results and complete LIMS data entry in a timely manner. Perform peer review of QCdata, review, and approval in LIMS.

· Adhere to all effective STM’s/SOPs and safety requirements and document laboratory workconsistent with cGMP requirements.

· Perform preventative maintenance / calibration on laboratory equipment and demonstrate proficiency in their use and maintenance in accordance with established procedures.

· Execute critical reagent and standard qualification studies and write protocols/reports with supervisory or senior analyst guidance. · Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.

· Make detailed observations during performance of experimental tasks; obtain and interpret experimental data with supervisory guidance.

· Contribute to and provide input for troubleshooting/laboratory investigation efforts. Perform investigative testing as assigned.

· Write clear and concise assay forms, TMDs, and SOPs. Contribute to protocols, technical studies, and reports under supervisory or senior analyst guidance. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.

· Provide training and assistance to peers and junior staff in an effective manner. · Execute development and validation studies and contribute to protocols/reports.

· Identify opportunities for improvements within QC procedures and documentation.

· Perform assigned tasks effectively with minimal supervision. The above statements are intended to 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

· University degree or technical diploma in chemistry, biology, microbiology, or related field ofstudy.

· Minimum two to four years of directly related experience in a recognized professional ortechnical/scientific field. Experience in a pharmaceutical cGMP environment is an asset, but isnot required.

· Proficient in Microsoft Office - Word, Excel, PowerPoint.

· Knowledge of pharmaceutical GMPs.

· Knowledge of regulatory guidance.

· Knowledge of laboratory techniques and safety precautions.

· WHMIS and biohazard safety awareness.

· Competent in laboratory safety and generally-accepted lab practice, including maintainingadequate written laboratory records.

· Ability to work in a fast paced and highly regulated environment.

· Able to multi-task and adapt to changing priorities.

· Able to communicate and articulate information in both written and verbal forms.

· Strong organizational and interpersonal skills; can work collaboratively with others.

· Able to interpret analytical data to support research and development work.

· Able to contribute ideas/solutions to aid in troubleshooting and investigations.

· Successful completion of Emergent's security clearance is required.

· This role requires successful completion of a pre- employment medical.

· The ability to work day, evening or overnights is required.

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.