Quality Assurance Associate I

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with over 30 years of experience in developing products for CNS diseases. The Quality Assurance Associate I will support the company's Quality Assurance and compliance programs by initiating and reviewing documentation, maintaining compliance systems, and performing inspections of GMP facilities.

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 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 Skills 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 Ability to work independently, as well as ability to function as a team player Ability to accept personal accountability for successful job performance 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 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 arenaflex 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 Position may require 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 A second language is a plus Familiar with internal and external auditing is a plus Benefits Opportunity to participate in employee stock purchase programs Performance-based bonus programs Company Overview We are a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. It was founded in 2005, and is headquartered in Rockville, Maryland, USA, with a workforce of 201-500 employees. Its website is Apply tot his job Apply tot his job Apply To this Job