BioAgilytix

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.

The Laboratory Monitoring and Calibration Specialist is responsible for implementation and oversight of all laboratory environmental monitoring systems (EMS) at BioAgilytix’s Durham laboratories. He or she collaborates with internal and external stakeholders on issues associated with the installation, maintenance, and operation of environmental monitoring equipment and systems. The Laboratory Monitoring and Calibration Specialist is responsible for addressing and resolving regulatory and client questions, providing training, and managing the coordination and oversight of the response team.

This is a 6-month contract position, with the possibility of going permanent depending on performance and company needs.

Essential Responsibilities:

• Ensures the Environmental Monitoring System (EMS) is maintained in a compliant state
• Organizes, trains, and manages the EMS Response team; ensures timely response to all system alarms
• Develops, implements, and maintains EMS validation documents in internal Quality Management Systems
• Serves in the capacity of System Owner for Environmental Monitoring System (EMS); responsible for execution of any changes to the validated system
• Responsible for coordination of all appropriate deviations and investigations associated with the system
• Performs reviews of system events on a scheduled basis
• Collaborates with vendor(s) to facilitate installation, maintenance, performance monitoring, and repair of the EMS
• Supports scientific teams through expanding lab EMS needs, as appropriate
• Provides technical support and training to scientific teams; this includes but is not limited to using the EMS and any other support required to ensure proper management of the EMS
• Responsible for troubleshooting technical issues that arise in the lab and in the use of the EMS

Minimum Preferred Qualifications: Education/Experience

• High School diploma
• Not less than six (6) years' experience in a GxP-regulated laboratory or sample management environment

Preferred Credentials:

• Associate degree in molecular biology, biochemistry, immunology, biotechnology, or related field
• Not less than five (5) years’ experience in sample management or GxP-regulated laboratory environment

Minimum Preferred Qualifications: Skills

• Working knowledge of GxP regulations
• Working knowledge of or familiarity with laboratory equipment and environmental monitoring
• Understanding of the equipment qualification and software validation processes for 21CFR Part 11 systems
• Versatility, flexibility, and willingness to work within constantly changing priorities; ability to work under pressure and tight deadlines in a fast-paced team environment
• Acute attention to detail
• Ability to take direction and follow standard operating procedures and best practices
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly while delivering high quality results
• Excellent written and verbal communication skills; ability to communicate concepts to multiple audiences
• Strong interpersonal skills with the ability to work with all levels of management and employees
• Ability to take direction and follow standard operating procedures and best practices
• Advanced proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
• Ability to work collaboratively and effectively with a diversity of individuals across at all organizational levels, in multiple departments and functional areas

Supervisory Responsibility:

• This position has no supervisory responsibilities

Supervision Received:

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment:

• Primarily laboratory/clinical and office 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

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 lab and office equipment
• Frequent mobility needed
• Frequent crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and laptop computer, with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
• 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 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.