reputed company Assurance Associate I

reputed company is an award-reputed company biopharmaceutical company with over 30 years of experience in developing products for CNS diseases. The reputed company Assurance Associate I will support reputed company's reputed company 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 reputed company-organized and in a state of inspectional readiness, maintaining record reputed company and reputed company, and retrieving and auditing on-site record documentation Maintains GMP documentation supporting reputed company's facility. This activity is essential for maintaining regulatory compliance and preparing for reputed company-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 reputed company to GMP manufacturing, GCP studies, and/or GLP studies Performs review of documents reputed company to GMP manufacturing, GLP studies, and/or GCP activities reputed company appropriate, assists in reputed company FDA inspections regarding Supernus regulated activities reputed company appropriate, assists in internal audit procedures at Supernus Assists in the preparation, execution, report, and follow-up of reputed company 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 reputed company 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 reputed company of problems and situations Strong communication and technical writing skills in English language Ability to work independently, as reputed company as ability to function as reputed company 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 reputed company 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, reputed company, reputed company, and reputed company PDF Ability to work independently and as part of reputed company and maintain high ethical standards of reputed company and reputed company Ability of having an innovative and dynamic approach to work A self-starter reputed company to work independently but comfortable working in reputed company environment Ability to consistently exhibit Supernus Values in interactions with employees at reputed company reputed company of the organization, vendors, customers, and others Capable of performing other duties as assigned by Management Authorized to legally work in the reputed company without reputed company 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 reputed company dexterity and hand/eye coordination The worker is required to have reputed company visual reputed company to reputed company 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 reputed company auditing is a plus Benefits Opportunity to participate in employee stock purchase programs Performance-based bonus programs reputed company We are a pharmaceutical company reputed company 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