LIMS Administrator

Career Opportunity

Your Vision. Our Mission. For Patients.

Abzena is proudly opening a brand new, state of the art manufacturing facility in Sanford, NC. We are seeking a Laboratory Systems Administrator to join our IT Department who will be responsible for responsible for the oversight and administration of all laboratory computerized systems (standalone and enterprise) in a controlled pharmaceutical laboratory environment.

As a new state of the art facility, you will be a pioneer of our organization. If you meet our qualifications, find joy in doing this type of work for partners and towards treatment for patients, and would like to be part of an inclusive, agile, and learning culture - we would like to hear from you!

Responsibilities

• Lead and manage projects involving procurement, integration and implementation of new and upgrades of laboratory software, instruments, applications and information
• Drive compliance, quality and safety in planning, implementing and maintaining of all new and existing validated/applicable computerized equipment, instruments and information systems.
• Create, revise, review, approve and/or provide input and guidance to Computer System Validation (CSV) documentation, validation related documents, change control documentation and Good Manufacturing Practices (GMP) documentation such as Standard Operating Procedures (SOPs) (where applicable).
• Promptly report deviations, and recommend and execute preventive and corrective actions to continuously improve the quality of laboratory
• Create, coordinate, implement, and maintain data integrity policies in the laboratory to comply with regulatory guidance’s and
• Serves as the point of contact for troubleshooting/issue resolution of laboratory computerized
• Develop and maintain knowledge and understanding of laboratory systems, equipment, instrumentation, and
• Responsible for timely backup of instrument electronic data for all laboratory computerized
• Communicate and collaborate with laboratory management, business stakeholders, Information Technology (IT) department, technical resources, vendors and
• Multi-task by working on several simultaneous
• Conducts user-training sessions for users
• Participate in internal and external audits (when applicable), including Food and Drug Administration (FDA) and customer audits.

Qualifications

Mindset and Behaviors

· Exemplifies a growth mindset.

· Thrives in a start-up, agile work environment.

· Thrives in a diverse, inclusive, team-centric environment.

· Passionate about learning and open to feedback.

· Believes in shared accountability across functions and levels.

· Described as curious, organized, resourceful, and thoughtful.

· Operates to the highest ethical and moral standards.

• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.

Must-Have

• 5 years of experience in the pharmaceutical
• Knowledge of pharmaceutical analytical laboratory procedures and USP
• Experience working in pharmaceutical industry and/or analytical laboratory
• Demonstrated experience with computer system validation and system lifecycle methodology is a must
• Independent experience and knowledge of the Empower Chromatography Data System.
• Knowledge of GMP, Industry Guidelines (ICH/FDA)
• Sound knowledge of 21CFR Part 11 compliance
• Highly organized individual with attention-to-detail
• Comply with all cGMP requirements and Company policies, procedures, rules and regulations
• Must possess excellent verbal and written communication skills
• Strong analytical and problem-solving skills
• Demonstrates ability to prioritize conflicting demands
• Performs duties with minimum supervision
• Executes assigned tasks within established schedule
• Knowledgeable with MS Office applications (Word, Excel, Access, Outlook Excel)

Nice-to-Have

· Independent experience and knowledge of the Biovia OneLab LIMS and Electronic Laboratory Notebook is preferable.

Work Schedule and Travel Requirement

· Regular business hours, additional support as required by the project’s schedules.

· Ability to travel between Abzena sites (Bristol PA, San Diego CA, and Sanford NC)

Physical/Mental Requirement

· Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.

Great Benefits:

· 100% Employer Paid Health, Dental, and Vision Benefits

· 100% Employer Paid Basic Life & AD&D, Short-Term Disability, Employee Assistance Program

· 5% 401k Employer Contribution through Fidelity

· 23Days of Paid Time Off, increasing to 28 days after 5 years of employees

· Tuition Fee Reimbursement up to $5, 250 per year for degree, certification, development programs

Abzena is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identify and expression, parental status, protected veteran status, disability/handicap status, national origin, age, disability, citizenship status, marital status or any other characteristics protected by applicable laws, regulations and ordinances.

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift

Work Location: One location