LABORATORY SYSTEMS SPECIALIST
Perform system administrator duties to support a variety of validated laboratory systems. This includes training of new users on login procedures and data security, as well as providing support and assistance to users for routine requests and basic troubleshooting. Laboratory systems covered in the scope of this position include an environmental monitoring system, a Laboratory Information Management System (LIMS) and chromatography software.
Essential Duties & Responsibilities
- Responsible for maintaining data security and data integrity.
- Managing user access and functionality.
- Perform changes and updates in accordance with established change control procedures.
- Assist with troubleshooting of basic hardware/software issues.
- Provide training to users on system security and user login procedures.
- Assist with computer software validation activities.
- Participate in the documentation of annual assessment of laboratory systems.
- Strong interpersonal and communication skills, high attention to detail, and the ability to organize and prioritize while managing multiple priorities.
- Performing periodic reviews (monthly/quarterly) of system logs and identifying any issues.
- Revision of Standard Operating Procedures related to Laboratory Systems.
Non-Essential Duties & Responsibilities:
- Assist with incident investigation and CAPA
- Assist with hardware qualifications (acquisition clients and/or servers)
Knowledge & Other Qualifications:
- BA/BS degree in a science-related discipline or equivalent combination of education and experience
- 3 + year practical related experience
- Good documentation, communication and problem-solving skills
- Ability to manage multiple tasks
- Familiarity with environmental monitoring systems, LIMS and/or chromatography software
- Knowledge of 21 CFR Part 11 and GAMP 5 is preferred
- Strong organizational skills with attention to detail and accuracy
- Working knowledge of Microsoft Office products (Excel, Word)
- Ability to work independently and as part of a team.
- Maintain high ethical standards regarding data integrity and data security.
- May perform other duties and responsibilities as assigned or directed by Management.
- Authorized to legally work in the United States without visa sponsorship.
Physical Requirements / Work Environment
- Position requires prolonged sitting, and some kneeling, bending.
- Position also requires the ability to push, pull, drag and/or lift to 20 pounds.
- Position requires manual dexterity and hand/eye coordination as well as repetitive hand movement using a computer keyboard and mouse.
- The worker is required to perform activities such as transcribing data.
- The worker is not substantially exposed to adverse environmental conditions.
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.