QA Auditor III at Amneal Pharmaceuticals LLC (J0P) in Brookhaven, New York

Job Description:

Description:

QA Auditor III will perform all job functions of QA Auditor II and following job functionsReview completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria. Manage and monitor Hold and Reject Cages located at Brookhaven and Yaphank warehouses. Review and assists in the release, hold and reject program involving finished products, raw materials, packaging components and labeling components. Identify materials and apply hold, accept, and release labels on Batch Folders and material containers whichever is applicable as per Release, Hold and Rejection programs. Update status of Hold, Reject and Release in JDE program based on movement of materials and investigation decisions. Maintain logbooks and spread sheets for Hold and Reject Materials. Initiate material rejection forms and distribute among internal departments for approvals of rejected materials initiated through investigations. Coordinate and confirm with warehouse for destruction of rejected materials which are approved through Material Review Board. Prepare and submit QA Assessments required for investigations. Monitor, issue and manage EVENTS created by Manufacturing, Engineering and other departments. Review and Update SOPs for Quality Assurance Department. Generate batch record error reports based on the errors entered in AAS by all auditors. Mentor and train QA auditors for review of batch records, checklists, and SOPs. Prepare training documents for SOP trainings and other GMP training related to quality systems and programs. Maintain and prepare training reports for all QA employees. Perform and prepare report of visual examination of customer returned goods, customer complaint samples, retain samples and in Quality Complaint investigations. Review production batch records for documentation completeness and accuracy and release of Batch Records and update Back Order files managing by department. Update and report daily releases to senior management. Communicate accurate and up-to-date batch record status reviews to management and co-workers.Works on multiple projects in a concurrent manner on a routine basis as per assignments by QA Manager. Assist in training and mentoring a variety of personnel on the use of electronic data systems. Maintain spreadsheets and audit database with relevant records and information pertaining to daily activities of QA audit department

Essential Functions:

• All requirements of QA Inspector III and QA auditor II, in addition to assisting the supervisor in maintaining documentation and training for QA inspectors and auditors as well as maintaining the area training matrix


• Will review annual Stability Check Lot Program, hold reconcile NOI batches in JD Edwards, annual cleaning validation cleaning program tracking


• Will assist prioritizing and completing reviews of manufacturing records and packaging orders in a timely manner.


• Will be involve in business critical sample submissions and tracking to respective labs.


• Will be responsible in data collection for closure of investigations, assessments, planned deviations


• Analyze RFT Data and provide trending reports to QA/OPS Supervisors and Managers.

Additional Responsibilities:

• Must be able to fill in for In-process QA inspectors / auditor when circumstances dictate.

Education:

• High School or GED - Required


• Bachelors Degree (BA/BS) - Preferred

Experience:

• 3 years or more in QA or related field

Skills:

• Good basic math knowledge and excellent attention to details - Intermediate


• Excellent organizational skills with proficiency in MS Word, Excel, and Powerpoint - Intermediate


• Ability to produce sufficient work within the stipulated time - Intermediate


• High energy level and organizational skills - Intermediate


• Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging - Intermediate


• Microsoft Word, Power Point and Excel working knowledge and willingness to learn other softwares such as QUMAS, JDE and AAS - Intermediate

Specialized Knowledge:

• Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.