Job Summary:

Responsible for activities related to manufacturing equipment and instrument qualification and calibration activities. In addition, this position will participate in validation of computer systems and software applications used for GxP purposes. The range of tasks allows for growth in a variety of skillsets.

Essential Duties & Responsibilities:

• Perform system administrator duties to support GxP validated computer systems (e.g. Empower)
• Perform and/or review calibrations of laboratory instruments and GMP equipment (e.g., chromatographic systems, dissolution units, tablet counters, stability chambers).
• Draft, perform, and/or review qualification protocols.
• Initiate quality records (e.g. change control, deviation).
• Create purchase order requisitions.
• Create or revise Standard Operating Procedures.
• Responsible for documenting activities in accordance with Good Documentation Practices.
• Review contractor documentation for services provided.
• Participate in troubleshooting of equipment or software issues.
• Participate in computer software validation activities as assigned (e.g. running test scripts).
• Participate in Periodic Reviews of Validated GxP Systems.
• Participate in scheduling of calibration/preventative maintenance for equipment and lab instruments.
• On call 24/7 as part of a rotating schedule to respond to environmental chamber excursions.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Assist with Supplier Management activities (e.g. communication for scheduling)
• Provide calibration and/or instrument use training to laboratory personnel, as applicable.
• Assist Department Management by identifying the need for qualification and/or validation testing when implementing new equipment /software systems.

Supervisory Responsibilities:

• N/A

Knowledge & Other Qualifications:

• BA/BS degree in a computer science or other science-related discipline.
• 2+ years of practical related experience in a GxP environment.
• Experience with GMP is required.
• Experience with instrument calibrations is required.
• Experience with qualification and/or validation is preferred.
• Experience with a Quality Management system is preferred.
• Ability to understand and follow written procedures.
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel.
• Good Documentation Practices and ALCOA+.
• Knowledge of 21 CFR Part 11 is required.
• Familiarity with environmental monitoring systems, LIMS and/or chromatography software is required.
• Knowledge of GAMP 5 is preferred.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Position may require prolonged sitting, prolonged standing, bending, and some kneeling/crouching.
• 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 not substantially exposed to adverse environmental conditions.
• Will be required to work in a clean laboratory environment and wear personal protective equipment to include at a minimum: safety glasses or goggles, and lab coat.

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.