Senior Quality Assurance Associate

Job Summary:

Responsible for supporting the Company's Quality Assurance and quality management systems by initiating & reviewing documentation, including executed batch records for Commercial products, deviations, and change controls.

Essential Duties & Responsibilities:

• Review of GMP documentation from commercial contract manufacturing organizations (CMO); including line clearances, control of raw materials and equipment cleaning processes.
• Communicating with external CMOs and internal stakeholders to ensure the timely release of material.
• Performing review of deviations and change controls from commercial CMOs.
• Initiation of quality records (e.g. change control, deviation).
• Performing CAPA actions as assigned by management.
• Maintaining the Quality management systems in accordance with U.S. regulations and internal standards.
• Supports management in their responsibilities and tasks.
• Mentors junior staff members.
• Assist in development and maintenance of training materials for all aspects of job functions.
• Lead and/or support continuous improvement initiatives.
• Ensure the collection, maintenance and communication of Quality Metrics and Key Performance Indicators.
• Build and maintains positive relationships with CMO representatives to promote quality, safety, and efficacy of products.
• Initiate new Standard Operating Procedures as needed.
• Review Standard Operating Procedures on behalf of Quality Assurance.
• Revise existing Standard Operating Procedures as needed.
• Stays current with CFR and FDA guidance documents to ensure that Supernus' compliance policies are up to date.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• Participate in internal audits or external audits as needed
• Participate in FDA inspections regarding Supernus regulated activities.
• Participate in Internal Audits of QA
• Perform training activities as assigned.

Supervisory Responsibilities:

• N/a

Knowledge & Other Qualifications:

• BS degree in a computer science or other science-related discipline.
• Minimum of 4+ years of practical related experience.
• Experience with GMPs, GCPs, and/or GLPs is required.
• Experience with pharmaceutical equipment, utilities, and validation concepts is required.
• 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.
• Knowledge of Good Documentation Practices and ALCOA+.
• Strong communication and technical writing skills in English language.
• Ability to work efficiently and accurately to meet set goals and timelines, and ability to pay attention to detail.
• Ability to work in a fast paced and flexible work environment where priorities can change.

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:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
• The worker is not substantially exposed to adverse environmental conditions.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $80,000 to $100,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.

Limitations and Disclaimer:

The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees we be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an "at-will" basis.

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

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.