Analyst I, QC Laboratory Services

Emergent BioSolutions; Winnipeg; On-site; CAD 45,000 - 75,000; Full time

Job summary

Emergent BioSolutions is seeking an Analyst I, QC Laboratory Services to perform GMP compliant testing supporting Raw Material testing, in-process, finished product release and stability, as well as nonclinical/clinical studies. The role includes testing for assay and process validations and release of lab materials such as media and standards.

Responsibilities include routine testing, data review, sample handling within timelines, and maintaining accurate lab records in a highly regulated

Qualifications

• University degree or technical diploma in microbiology, biology or related field of study.
• Experience in a pharmaceutical cGMP environment is an asset, but is not required.
• Basic knowledge of Microsoft Office - Word, Excel
• Basic knowledge of pharmaceutical GLPs and GMPs
• Knowledge of laboratory techniques and safety precautions
• WHMIS and biohazard safety awareness
• Ability to work in a fast paced and highly regulated environment
• Able to multi-task and adapt to changing priorities
• Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records
• 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

Responsibilities

• Perform routine laboratory testing procedures including analyzing and reviewing data
• Receive and test samples within required timeframes
• Receive, prepare, test, release materials used for QC testing (e.g., media, standards, biological indicators, cultures)
• Document laboratory work consistent with GDP and GxP requirements
• Maintain laboratory records, ensuring documents are reconciled and filed immediately after completion
• Maintain inventory of supplies, reagents, standards, solutions, cultures, etc.
• Perform preventative maintenance on laboratory equipment
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures
• Contribute to investigations to aid in determination of root cause
• Adhere to all effective TMDs/SOPs and safety requirements
• Maintain the lab and testing following applicable regulations and guidelines, including USP, EP, GMP, FDA, Health Canada and EU requirements
• Work effectively and productively with other team members and on independent assignments
• Prepare and Autoclave supplies and garbage
• Ability to successfully complete a pre-employment medical

Skills

Microbiology knowledge

GxP awareness

Communication skills

Multitasking

Team collaboration

Education

University degree or technical diploma in microbiology/biology

Tools

Microsoft Office

Job description

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Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary

The Analyst I, QC Laboratory Services performs GMP compliant testing as required to support Raw Material testing, In-process, Finished Product release & Stability or nonclinical/ clinical studies. The Analyst I also perform testing required to support assay and process validations. He/She will perform testing to support release of lab specific material (media, standards).

Responsibilities

• Perform routine laboratory testing procedures including analyzing and reviewing data
• Receive and test samples within required timeframes
• Receive, prepare, test, release materials used for QC testing (for example: media, standards, biological indicators, cultures, etc.)
• Document laboratory work consistent with GDP and GxP requirements
• Maintain laboratory records, ensuring documents are reconciled and filed immediately after completion.
• Maintain inventory of supplies, reagents, standards, solutions, cultures, etc required to perform testing
• Perform preventative maintenance on laboratory equipment
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures
• Contribute to investigations to aid in determination of root cause
• Adhere to all effective TMDs/SOPs and safety requirements
• Maintain the lab and testing following applicable regulations and guidelines, including but not limited to USP, EP, GMP, FDA, Health Canada and EU requirements
• Work effectively and productively with other team members and on independent assignments
• Prepare and Autoclave supplies and garbage
• Ability to successfully complete a pre-employment medical

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 microbiology, biology or related field of study
• Experience in a pharmaceutical cGMP environment is an asset, but is not required.
• Basic knowledge of Microsoft Office - Word, Excel
• Basic knowledge of pharmaceutical GLPs and GMPs
• Knowledge of laboratory techniques and safety precautions
• WHMIS and biohazard safety awareness
• Ability to work in a fast paced and highly regulated environment
• Able to multi-task and adapt to changing priorities
• Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records
• 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

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

Emergent prepares those entrusted with protecting their communities against current and future health threats.

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
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough 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.