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Quality Assurance Specialist/Associate

Company: Novelstar Pharmaceuticals Inc.
Location: Cranbury
Posted on: May 16, 2022

Job Description:

Quality Assurance Specialist/Associate Locations: Cranbury, NJ Functions: Quality Assurance and Compliance Job description Novelstar Pharmaceuticals Inc. (A Fosun Pharma Company) is hiring a QA Specialist/Associate, located in Cranbury, NJ. If you are looking for a great pioneer opportunity to develop your career, be empowered to take charge of your future at Novelstar. Novelstar Pharmaceuticals, Inc. is a Fosun Pharma (Fosun Pharmaceutical (Group) Co., Ltd) company. Our mission is to develop novel pharmaceutical drug products (NDA), deliver high quality generic products (ANDA) and provide service to pharmaceutical industry. Our vision is to be a robust growth innovation leader and partner in global healthcare to enhance people`s lives. The Quality Assurance Specialist/Associate will participate in and conduct daily activities in accordance with Quality Operations and Systems processes to support several Novelstar Pharmaceuticals areas such as Manufacturing, Warehouse, Laboratory, between others. The position will be responsible for the lifecycle management and maintenance of Quality documentation such as, but not limited to: Standard Operating Procedures (SOP), Training Records, Logbooks, Master Batch Records, Investigations, Change Control, CAPAs, Vendors, Metrics, Protocols, Reports, Quality Agreements, Equipment Qualification and/or Validation Documentation. Will actively participate in collecting data, building databases, and developing technology solutions to support the Quality Systems organization. In addition, will participate in executing Quality Operations functions to support R&D formulation, cGMP manufacturing and packaging processes. This position will report to the Director of Quality. Key Responsibilities include but are not limited to: -- Responsible for maintaining and administrating all quality documentation, these documents must be organized, filed/achieve, and inventory for easy access and retrieval within the Documentation designated area. Considered the custodiam of all GMP records. -- Assist in the issuance of effective SOP and distribution of related documentation to the support areas to assure the effective version is always available. -- Responsible for all the training file records, these must be periodically reviewed to assure all employees have their trainings up to date against each training matrix. -- Assist the trainer to coordinate training session, make up session and collecting of training forms and/or training assessment (test), as appliable to assure compliance of the training program. -- Responsible for the management all plant-wise Logbooks, this task includes the creation, issuance and filing of return logbooks. -- Assist in authoring SOPs and/or other quality documents such as protocol, reports, between other. -- Responsible for the assignment of document equipment identification numbers, as applicable. -- Assist in the preparation of quality reports, using different tools such as power-point pentation---s and/or excel, as required. -- Collects site data to measure the quality performance; data can be measured for the preparation of quality metrics. -- Inspection, documentation, and management of GMP retain samples. -- Assist in the routing for approval different quality documents, such as SOP, Change Controls, Investigations, and/or Corrective Actions, as required. In addition, assists in the monitoring of open document records timelines (e.g., track open records) up to closure. -- Responsible for the plant equipment PM/Calibration database, the data base will include the equipment PM/Calibration frequency and requires periodic reviews to assure compliance from the functional areas. -- Acts as the incoming quality person to receive and sample GMP material for analysis and inspection process. -- Review and approve GMP material for pilot/pivotal for BE/PK batch manufacturing. -- Issuance of approve manufacturing/packaging records for the manufacturing of pilot/pivot drug products for BE/PK studies. -- Assist in the review and approval of executed manufacturing records to ensure that the documents, raw materials, in process products and final products are compliance to cGMP requirements. -- Assist in the release process of pilot drug products for BE/PK studies. -- Any other work to support R&D manufacturing. -- Facilitates and/or participates in any required meetings related to quality, as assigned. -- Complies with all company policies standards and procedures. -- Other duties assign by the supervisor. Qualifications and Requirement -- A bachelor---s degree required. Degree concentration in a scientific, engineering, or related pharmaceutical area is preferred. -- Minimum of 1 to 5-year experience working in a regulated quality environment (Pharmaceutical Industry preferred) within the Quality, Laboratory and/or Manufacturing areas. -- Ability to take initiative and work independently while effectively managing timelines required. -- Maintain cooperative working relationships with internal and external partners required. -- Ability to perform in fast paced environment and in stressful situations is required. -- Demonstrate ability for self-motivated with inherent can-do attitude. -- Additional domestic travel and internal travel as required 5%. -- Fluent in English (written and verbal). Knowledge and Skills -- Experience in current Good Manufacturing Practices (cGMP) pertaining to pharmaceutical. -- Good knowledge in computers, such as Office Tools (Microsoft Office, Excel, PowerPoint). -- Excellent organizational skills and proven experience working in a fast-paced environment. -- Possesses strong organizational, people skills /teamwork and detail oriented. -- Excellent verbal and written communication skills and positive attitude. -- Excellent computers skills (Microsoft Words, Excel, PowerPoint etc.). -- Ability to manage multiple priorities and projects concurrently. -- Problem solving skills and result oriented. Locations: Cranbury, NJ Functions: Quality Assurance and Compliance

Keywords: Novelstar Pharmaceuticals Inc., Trenton , Quality Assurance Specialist/Associate, Professions , Cranbury, New Jersey

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