Analyst I, QC Laboratory Services

Emergent Biosolutions•Winnipeg, MB

About The Position

Perform GMP compliant testing as required to support Raw Material testing, In-process, Finished Product 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. Participate in the execution of investigations, deviations, critical reagent and standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs and change controls. Provide training to peers in an effective manner.

Requirements

University degree or technical diploma in chemistry, biology, microbiology, or related field of study.
0-2 years directly related experience in a recognized professional or technical/scientific field and experience in a pharmaceutical cGMP environment is an asset, but is not required.
Basic knowledge of Microsoft Office - Word, Excel.
Basic knowledge of pharmaceutical GMPs.
Knowledge of laboratory techniques and safety precautions.
WHMIS and biohazard safety awareness.
Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate 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.
Able to contribute ideas/solutions to aid in troubleshooting and investigations.

Nice To Haves

HPLC expereince is an asset.

Responsibilities

Receive test samples, standards, chemicals, and reagents; maintain accurate laboratory records and inventory for all laboratory materials.
Demonstrate competence when analytical testing with supervisory or senior analyst guidance.
Be competent with analytical/biological/Compendia methodologies and techniques.
Report results and complete LIMS data entry in a timely manner. Perform peer review of QC data, review, and approval in LIMS.
Adhere to all effective STM’s/SOPs and safety requirements and document laboratory work consistent with cGMP requirements.
Perform preventative maintenance / calibration on laboratory equipment in accordance with established procedures.
Execute critical reagent and standard qualification studies.
Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
Make detailed observations during performance of experimental tasks.
Contribute to troubleshooting/laboratory investigation efforts under supervisory or senior analyst guidance.
Contribute to revision of assay forms, TMDs, and SOPs. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.
Provide training in basic QC tasks to peers in an effective manner.
Execute development and validation studies.
Identify opportunities for improvements within QC procedures and documentation.
Perform assigned tasks effectively with supervisor or senior analyst oversight.
Ability to pass a pre-employment medical & criminal background check.