Job Summary
Perform GMP compliant testing as required to support Raw Material testing, In-process, FinishedProduct 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.
Contribute to and author investigations, deviations, critical reagent and standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs and change controls.
Train and provide assistance to junior staff; provide training to peers/junior staff in an effective manner.
Responsibilities
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Receive test samples, standards, chemicals, and reagents; maintain accurate laboratory records and inventory for all laboratory materials.
- Demonstrate proficiency when performing analytical test methods with minimal supervisory guidance.
- Be proficient in a variety of 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 and demonstrate proficiency in their use and maintenance in accordance with established procedures.
- Execute critical reagent and standard qualification studies and write protocols/reports with supervisory or senior analyst guidance. · Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
- Make detailed observations during performance of experimental tasks; obtain and interpret experimental data with supervisory guidance.
- Contribute to and provide input for troubleshooting/laboratory investigation efforts. Perform investigative testing as assigned.
- Write clear and concise assay forms, TMDs, and SOPs. Contribute to protocols, technical studies, and reports under supervisory or senior analyst guidance. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.
- Provide training and assistance to peers and junior staff in an effective manner. · Execute development and validation studies and contribute to protocols/reports.
- Identify opportunities for improvements within QC procedures and documentation.
- Perform assigned tasks effectively with minimal supervision. 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.
- University degree or technical diploma in chemistry, biology, microbiology, or related field of study.
- Minimum two to four years of directly related experience in a recognized professional or technical/scientific field. Experience in a pharmaceutical cGMP environment is an asset, but is not required.
- Proficient in Microsoft Office - Word, Excel, PowerPoint.
- Knowledge of pharmaceutical GMPs.
- Knowledge of regulatory guidance.
- 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 to support research and development work.
- Able to contribute ideas/solutions to aid in troubleshooting and investigations.
- Successful completion of Emergent's security clearance is required.
- This role requires successful completion of a pre- employment medical.
- The ability to work day, evening or overnights is required.
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 .
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