Analyst I, QC Laboratory Services

Emergent BioSolutions, Inc.; Winnipeg; On-site; CAD 52,000 - 76,000; Full time

Job summary

Emergent BioSolutions, Inc. in Winnipeg, MB, seeks an Analyst I, QC Laboratory Services to perform GMP-compliant testing supporting Raw Material, In-process, Finished Product release and Stability studies, and support validations.

Responsibilities include data analysis, documentation per GDP/GxP, inventory upkeep, equipment maintenance, and ensuring adherence to USP, EP, GMP, FDA and Health Canada requirements. Strong organizational and communication skills are essential.

Qualifications

• University degree or technical diploma in microbiology or related field.
• Experience in a pharma cGMP environment is an asset.
• Basic knowledge of MS Office (Word, Excel).
• Knowledge of GLPs and GMPs.
• WHMIS and biohazard safety awareness.
• Strong written and verbal communication skills.
• Ability to work in a fast-paced, highly regulated environment.

Responsibilities

• Perform routine GMP-compliant laboratory testing and data review.
• Receive, test, and release samples and materials for QC.
• Document work per GDP/GxP; maintain records.
• Maintain inventory of supplies and equipment; autoclave as needed.
• Contribute to investigations to determine root cause.
• Adhere to SOPs and safety requirements; comply with regulatory guidelines.
• Work effectively with team and independently as required.
• Prepare and autoclave supplies; complete required pre-employment medical.

Skills

Microsoft Office

Lab safety

Analytical thinking

Written & verbal communication

Education

University degree or technical diploma in microbiology or related field

Tools

Autoclave

Job description

Preparedness today, safer tomorrow.
Emergent is a leading public health company that delivers protective and life-saving solutions to

Preparedness today, safer tomorrow.
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.