Quality Assurance Associate I

Supernus • Rockville, MD

59d • $52,000 - $67,000

About The Position

The Quality Assurance Associate I, will 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.

Requirements

• B.S. in a life sciences discipline, with 0+ 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.
• 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.
• 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.

Nice To Haves

• Familiar with internal and external auditing is a plus.

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.
• 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 SOPs 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.

Benefits

• At Supernus, we offer a competitive compensation package that reflects your experiences and contributions.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Number of Employees: 501-1,000 employees