Analyst I, QC Laboratory Services

Emergent Biosolutions•Winnipeg, MB

About The Position

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).

Requirements

University degree or technical diploma in microbiology, biology or related field of study.
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.
Ability to pass pre-employment medical and background check.

Nice To Haves

Experience in a pharmaceutical cGMP environment is an asset, but is not required.

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