QC Laboratory Analyst I – GMP Microbiology & Testing

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

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