Senior QA Specialist (Hybrid Remote) 3 days onsite
Hawthorne, NY US
Reports To Manager, QA (Compliance and Quality Operations)
The position of Quality Assurance Associate is responsible for execution of the day-to-day operational activities of Quality Assurance (QA) department for In-Market Quality. Knowledge and experience are required across wide range of QA responsibilities including product quality complaint investigations, deviation and CAPA investigations, In Market Label Artwork Review, SOP Document Management, Batch Release and product disposition, Product Reworks, audit program, annual product reviews, contract service provider oversight and issue resolution, GMP Training, Technical Quality Agreements. This role is responsible for assigned activities to assure internal compliance and marketed products meet applicable regulatory requirements. All work needs to be accomplished in accordance with GMP requirements. This role is responsible for an effective support and continuous process improvement;manages and promotes the culture of quality and compliance.
Duties and responsibilities
·Execute finished product releases and approval of the Work Orders;review Certificates of Analysis and Certificates of Manufacture to provide final disposition of all products.
·Ensure execution of the Full Batch Release Program.
·Review the product quality complaint investigations conducted by internal and Contract Service Providers;review and documents investigations in Product Quality Complaint records.
·Provide quarterly trending of Product Quality Complaints to management and other departments as necessary. Review trending information and investigate as necessary to improve customer experience and quality of products.
·Assess Quality Events that occur during holding/warehousing of the products;initiate and manage deviations and CAPAs to completion.
·Ensure Fulfillment and Rework Centers are audited on a timely basis, in alignment with procedure(s).
·Approve Annual Product Reviews to verify consistency of the process, assess trends, and determine if there is a need for changes in specifications, production, manufacturing, and/or control procedures.
·Execute completion of the Post-Marketing Surveillance chapter of the Annual Product Review Reports.
·Responsible for maintenance, documentation, approval and control of Technical Quality Agreements/Quality Assurance with Fulfillment and Rework Centers.
·Maintain SOP Document Management, to ensure that relevant and understandable written procedures are available to the TPC organization as well as TPC suppliers.
·Compile data and metrics of quality systems for Quality Management Review.
·Revise finished good rework instructions received from Supply Chain, to ensure compliance and guarantee quality product. Distribute revised and approved rework instructions to applicable rework center(s).
·Review and approve artwork to ensure cGMP requirements are met.
·Review and approve warehouse temperature monitoring logs, to have an understanding of temperature levels throughout warehouses.
·Review transportation documents to ensure truck setting in compliance with USP 1079.
·Ensure applicable reports pertaining to Product Quality Complaints records, containing applicable data, are sent to appropriate individuals.
·Participate in multifunctional project teams to support introduction of new products and/or changes to current products;to ensure compliance with Quality System requirements.
·Perform other duties as assigned & providing overtime as needed
- Minimum of B.Sc. Chemistry or other associated field
- Minimum 5 years'experience in Quality Assurance or Quality Control in the pharmaceutical or related industry environment
- Experience in support of communications with Regulatory agencies officials such as USFDA
- Excellent knowledge of FDA guidelines and regulations
- Capable of leading by influence in matrix environment
- Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
- Experience in Quality electronic systems such as SAP and Trackwise is an asset