Quality Assurance Specialist II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the SUMMARYThe QA Specialist II provides advanced quality oversight and exercises judgment in product disposition investigations and change control. This role applies specialized knowledge to resolve quality issues lead investigations and ensure timely product release. QA Specialist II partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards. ROLE RESPONSIBILITIESEvaluate and approve batch documentation and exercise judgment in determining product disposition based on compliance quality oversight and guidance for manufacturing and testing activities including shop floor support inspection readiness walk-throughs line clearance in-process checks deviation and laboratory investigations change management SOP revisions and batch documentation identify and resolve non-conformances in manufacturing operations; recommend corrective and preventive actions to timely reviews and make informed decisions on batch acceptability and product effectively in a team environment and collaborate across departments with minimal guidance applying professional judgment under short timelines while maintaining quality standards. Collect analyze and report departmental data to support quality metrics and continuous improvement to training and mentoring Quality Assurance colleagues to strengthen team the ability to understand and demonstrate aseptic techniques and behavior required in aseptic processing areasApply knowledge of manufacturing operations and quality procedures to ensure compliance with regulatory requirements and proactively influence process issues identified during batch production or record reviews promptly to management demonstrating accountability and ownership of quality and approve SOPs Forms Logbooks and Master Batch Records for accuracy and regulatory in internal GMP audits and represent QA during customer and regulatory review and approval of SOPs and Master Batch Records to maintain compliance ERP transactions as applicable to ensure accurate documentation and system be willing to work weekends and holidays as needed to support business initiativesOther tasks assigned by management requiring application of professional judgment and quality QUALIFICATIONSBachelors degree in Chemistry Biology Microbiology Pharmacy Engineering or other science-related discipline or a minimum of 3 years experience in the Pharmaceutical or related industryExperience in Batch Record Review/Audit/DispositionThe ideal candidate will possess a combination of relevant education aseptic training and manufacturing/quality of cGMPs (USFDA Health Canada PIC/S and/or Eudralex).Demonstrated decision making ability related to Incident Investigation Corrective and Preventive Actions with emphasis on overall quality site priorities results and achievementsWorks in a team environment within own team and interdepartmental work under short timelines while maintaining quality have effective written and oral communication researches analyzes and presents data information Quality Auditor (CQA) Certification QUALIFICATIONSPosition requires vision acuity testing and onsite attendance this position cannot be performed on a remote or telecommute basis on a temporary short- or long-term candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified is required to sit stand and occasionally lift items (up to 25 pounds) performing the duties of this have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements including performing site and functional responsibilities responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.#LI-Onsite