Quality Compliance Specialist Department: Quality Location: Monroe, NC START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3322569&source=3322569-CJB-0) Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil. Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company. POSITION SUMMARY: Under the direction of the Senior Manager, Quality Compliance, the Quality Compliance Specialist is responsible for managing the investigation and resolution of Quality Systems notifications including, but not limited to: Complaints, Field Alerts and Recalls, Vendor and Contract Lab Qualifications, Internal and External Audits. This individual works closely with cross-functional teams at the site and abroad. This individual will routinely report on system and business process performance; proactively identifying, providing guidance and implementing process and system improvements to resolve complex issues in a timely manner. This position will also provide site representation for regulatory surveillance program. JOB RESPONSIBILITIES: Financial: Provide support in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site. Operational Excellence: + Ensures that complaints are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements. + Coordinates the reviews of relevant records, (e.g. batch records, quality control data, quality investigations, etc.) + Tracks quality system metrics related to complaints and creates detailed trend analysis reports. Prepares formal reports for complaint closing. + Ensure that site is in compliant with CGMPs in respect to internal/external regulations and procedures. + Provide support in evaluation of implementation for Global Policies and Procedures + Evaluates and assists in the implementation of new changes for the site. + Supports implementation of projects that improve site Quality and/or efficiency. + Keep track of certified auditors for internal audit and external audit (vendor/CTL) + Keep records maintained for audit reports pertains to vendors and CTL at site along with schedule. + Participate in regulatory surveillance program and work with CFT members for necessary changes to prevent similar observations at the site. + Provide support in handling of Field Alerts and Product Recall as required for marketed products + Approves creation or modification of Materials and Vendors. + Creates or modifies Quality view data such as: shelf life and Quality Info Record (QIR) based on Vendors qualification status. + Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate or vendor audits and audit readiness related activities. + Support internal and external/regulatory audits / inspections when required. Stakeholder: + Ensure site is in compliant with CGMPs and internal/external regulations and procedures. + Provide guidance and work with stakeholders from various departments to process complaints, internal and external audit CAPA and follow-up with external parties (Vendor/CTL) for audit closure. + Provide required support in Annual Product Review Innovation: + Establish, revise, review and continuously improve procedures for applicable Quality Systems. + Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target. Education: Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent Experience: Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience. Knowledge and Skills : Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry. Must be proactive, results-oriented with a strong attention to detail and strong time management skills. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. Ability to analyze details and perform structured decision-making on a daily basis. Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools. Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team. START YOUR APPLICATION (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3322569&source=3322569-CJB-0)