The Laboratory Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate infrastructure.
Essential Responsibilities
- Participates in implementation planning, qualification and/or validation of laboratory systems and software
- Authors and reviews validation deliverables (risk assessment, requirements specification, IQ/OQ/PQ, etc.)
- Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data integrity), following 21 CFR Part 11, Annex 11, GxP, and GAMP
- Completes periodic reviews of validated computer systems
- Performs administrative tasks for specialized scientific applications and other corporate systems; this may include but is not limited to installation, configuration, and maintenance of application servers for laboratory systems
- Follows standard operating procedures (SOPs) including those for account management, systems configuration, change control, and incident handling
Additional Responsibilities
- At all times, protect the security and integrity of company systems
- Other duties as assigned
Minimum Preferred Qualifications: Education/Experience
- Bachelor’s degree in computer science/engineering, or a related field
- Not less than five (5) years’ experience supporting scientific and enterprise systems, including but not limited to: application servers, Active Directory, virtualized infrastructure, and cloud-based systems, preferably in a regulated laboratory or research organization
- Not less than three (3) years’ direct hands-on experience with computer systems validation
Minimum Preferred Qualifications: Skills
- Proficiency in Computer System Validation, following GxP regulations and GAMP guidelines
- Advanced knowledge of Active Directory, Entra ID, Office 365, VMware, and other enterprise technologies
- Exceptional customer service and problem-solving skills
- Excellent written and verbal communication skills
- Strong interpersonal skills to work with all levels of management and employees
- Strong organizational skills to perform and prioritize multiple tasks seamlessly while delivering high quality results in a timely manner
- Acute attention to detail
Supervision Received and Supervisory Responsibility
- Receives minimal direction regarding prioritization and approval of proposed technical solutions
- Works independently to resolve issues following established SOPs and best practices
- Supports junior technicians to assist with advanced or specialized needs
- No supervisory responsibility
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.
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