An Associate Scientist, Quality is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. This may include responsibilities for product release. An Associate Scientist , Quality is expected to be able to lead and/or direct the work of others, to include establishing the scope of work assignments, experiments and work schedules/deadlines. The incumbent is expected to display a wide-degree of latitude, creativity, and self-management and to be able to independently manage multiple projects in addition to providing oversight and guidance to other team members as needed.
DUTIES AND RESPONSIBILITIES:
• Plan testing, analyze data and present that data clearly.
o Review corresponding documentation for completion including data capture, forms, logbooks, and/or batch records
o Ensure documentation is in compliance with ISO standards
o Create, coordinate and/or be the Technical Lead of any CAPA documents, such as NCMRs, DEV, VARs
o Coordinate and lead MRB meetings
o Ensure proper handling, quarantine and disposition of discrepant material
• Participation in general lab organization
o Maintain and update electronic inventory list database (using SharePoint and/or Access)
o Support 5S compliance
• Understanding and administrating laboratory safety precautions and proper use of personal protective equipment
• Incumbents should be able to develop, revise and implement SOPs/ Test Records/ and product specification documents.
• This role will supervise the work of others in all aforementioned areas of productivity and effectiveness
o Responsible for supporting, mentoring and documenting performance evaluation for direct reports
• Specific duties may vary depending upon departmental requirements
EXPERIENCE AND QUALIFICATIONS:
• Bachelor’s degree in life sciences, protein sciences, cellular/molecular biology, chemistry, biochemistry, biotechnology, or other related area is required
o Master’s degree is preferred
o Additional experience may be substituted for degree
• Minimum 2 years of experience in reagent, product or assay development in an industrial setting is preferred
• Training and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred
• Experience with quality document systems in an ISO/GMP regulated environment
• Management experience is a plus
• A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration
KNOWLEDGE, SKILLS AND ABILITIES:
• Experience with protein based immunoassays execution, development, and optimization
• Understanding of basic molecular biology techniques
• Logical problem solving and the ability to manage complex projects and meet timely deadlines
o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
o Effectively communicate performance goals and expectations
o Provide coaching and facilitate problem solving methodologies to team
• Proficiency in MS Office suite
o Experience with standard data analysis tools and databases (Excel, Access, SharePoint)
• The ability to multi-task and work productively in a demanding environment with changing priorities
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.
This position is performed in a standard office environment.