Job Summary: To support the Company's Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, performing inspections of GMP facilities, and mastering CFR and/or FDA guidance.
Essential Duties & Responsibilities:- Major responsibilities include reviewing GMP documentation, line clearances, and status control of raw materials and finish product. Participating in internal audits, keeping the information well-organized and in a state of inspectional readiness, maintaining record integrity and security, and retrieving and auditing on-site record documentation.
- Maintains GMP documentation supporting the company's facility. This activity is essential for maintaining regulatory compliance and preparing for pre-approval and general inspections by various regulatory agencies.
- Maintains the QA compliance systems in accordance with U.S. regulations and internal standards.
- Performs critical phase inspections related to GMP manufacturing, GCP studies, and/or GLP studies.
- Performs review of documents related to GMP manufacturing, GLP studies, and/or GCP activities.
- Participates in external audit of suppliers and vendors.
- When appropriate, assists in all FDA inspections regarding Supernus regulated activities.
- When appropriate, assists in internal audit procedures at Supernus.
- Assists in the preparation, execution, report, and follow-up of internal and external audits.
- Supports senior staff members in their responsibilities and tasks.
- Initiates new SOP's or revises existing SOP's for the QA department 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:- May review SOP's subject to QA review.
- May serve as a backup for training activities, regarding general compliance to the QA department responsibilities.
- May serve as a backup for documentation management activities, regarding general compliance to the QA department responsibilities and maintaining company's SOP systems.
Supervisory Responsibilities:Knowledge & Other Qualifications: - B.S. in a life sciences discipline, with 2+ years of experience in GMP, GCP, and/or GLP environment.
- Understanding of GMPs, GCPs, and/or GLPs, and their application to a wide variety of problems and situations.
- Strong communication and technical writing skills in English language. A second language is a plus.
- Ability to work independently, as well as ability to function as a team player. Ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers.
- 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.
- Familiar with pharmaceutical equipment, utilities, and validation concepts.
- Familiar with internal and external auditing is a plus.
- Excellent interpersonal and communication skills in English language (writing, speaking, and comprehension).
- Computer literacy with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.
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 requires prolonged sitting, prolonged standing, balancing, stooping, bending, and crouching; the ability to push, pull, drag and/or lift up to 20 pounds; normal manual dexterity and hand/eye coordination.
- 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 $71,000 to $90,000. 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.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
