Laboratory Systems Administrator (GxP)
Boston, MA
Lab Operations /
FT /
On-site
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
BioAgilytix is seeking a detail-oriented and proactive GxP Laboratory Systems Administrator to suppport the administration, development, and deployment of our laboratory systems. This role plays a critical part in supporting our GxP systems by defining standard business processes, configuring, testing, and validating software solutions, and deploying them across BioAgilytix sites. The GxP Laboratory Systems Administrator will ensure smooth, compliant, and effective system operation, providing ongoing support and optimization for these essential platforms.
Essential Responsibilities
- Effectively manage, support, and enhance laboratory systems while ensuring compliance with industry regulations and standards.
- Support and system administration for identified applications
- Perform *and lead investigation and resolution efforts for technical and business process issues
- Communicate technical issues and resolutions with users and department managers
- Escalate issues to application vendors as necessary
- Troubleshoot and collaborate with end users and departmental managers
- Maintain a high level of functional subject matter knowledge for the assigned applications
- Collaborate with Quality on initiatives and projects related to system implementation (e.g., integrations, data integrity and risk management).
- Perform periodic application review and management of user access
- Represent the application documentation in client and regulatory audits
- Contribute to computer system validation and computer software assurance projects, including change control as required by GxP Establish open communication between the business and Information Systems and Informatics
- Identify integration points with other systems (e.g., LIMS, Laboratory Equipment) and understand the technical architecture. Support data exchange activities with interfaced systems.
- Assist with incidents requiring troubleshooting and be the subject matter expert to investigate, troubleshoot, find resolution, and implement the resolution.
- Perform triage and escalate technical issues to Information Technology and Laboratory Support
- Coordinate release of new versions of software and firmware including into Development, Testing and Production environments
- Verify installation and operation of applications
- Document analysis and/or testing related to infrastructure changes. (e.g., operating system patches, significant network changes)
Additional Responsibilities
- Other duties as needed
Minimum Preferred Qualifications: Education/Experience
- Bachelor's degree in computer science or life sciences, other related field, or equivalent experience
- 4+ years’ experience related to the administration, operation, and maintenance of laboratory systems such as Laboratory Information Management Systems (LIMS), Chromatography Data Systems, microbiology laboratory instrumentation, and ancillary/supporting laboratory systems in a GxP environment
- Knowledge of CRO industry regulations, standards, and guidelines (GxP, CSV, GAMP5, 21 CFR Part 11, EU Annex 11, SDLC)
- Experience with regulated environment asset management applications
Minimum Preferred Qualifications: Skills
- Strong technical skills in system administration, software configuration, and maintenance.
- Proficiency in troubleshooting and resolving technical issues.
- Ability to understand and manage technical architecture and integrations.
- Strong analytical abilities to investigate, troubleshoot, and resolve complex issues.
- Ability to perform detailed analysis and documentation.
- Ability to clearly articulate technical issues and solutions.
- Strong ability to collaborate with cross-functional teams, including Quality, IT, and Laboratory Support.
- Experience in working with various stakeholders to achieve common goals.
- Strong organizational and time management skills.
- Ability to adapt to changing technologies and processes.
- Strong judgment and decision-making skills.
- Continuous improvement mindset.
- Proficiency in creating and maintaining detailed documentation.
- Ability to produce clear and concise reports for audits and reviews.
Supervisory Responsibility
- This position has no supervisory responsibilities at this time however may in the future
Supervision Received
- Frequent supervision and instructions
- Infrequently exercises discretionary authority
Working Environment
- Primarily office
- Primarily laboratory/clinical environment
- Exposure to biological fluids with potential exposure to infectious organisms
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
- Personal protective equipment required, such as protective eyewear, garments, and gloves
- Exposure to fluctuating temperatures on rare occasions
Physical Demands
- Ability to work in an upright and/or stationary position for up to eight (8) hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office and lab equipment
- Frequent mobility needed
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moving) objects, including office equipment, lab equipment, and laptop computer, with a maximum lift of 40 pounds
- Ability to access and use a variety of computer software
- Frequently interacts with others to obtain or relate information to diverse groups
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
Position Type and Expected Hours of Work
- This is a full-time, on-site position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
