Analyst I, QC Laboratory Services

Job Summary

The Analyst I, will perform GMP-compliant testing to support in-process testing, finished product release, and stability programs, including nonclinical/clinical studies and assay or process validations.
Maintain accurate laboratory documentation and perform preventive maintenance and calibration of laboratory equipment per established procedures. Participate in investigations and quality systems activities, including deviations, critical reagent/standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs, and change controls.
The ideal candidate will have prior experience with ELISA and bioassays.

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, 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.

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 biochemistry, 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 or regulated environment.
• Basic knowledge of Microsoft Office - Word, Excel.
• Basic knowledge of pharmaceutical GMPs.
• Knowledge of laboratory techniques and safety precautions.
• WHMIS and biohazard safety awareness.
• Proficient in laboratory safety and good laboratory practices (GLP), including maintaining complete and accurate written laboratory records.
• Previous experience with LIMS, Veeva and SAP is considered an asset.
• Willingness to work off-schedule shifts to support in-process manufacturing.
• 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.
• Able to work in a fast-paced, high-throughput environment and adapt to change, particularly in schedule.
• Able to lift up to 25 lbs.
• Successful completion of Emergent security clearance and a pre-employment medical is required.

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 .