Quality Assurance Specialist I

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the SUMMARYThe QA Specialist I provides quality oversight and compliance support for operations including equipment and material preparation aseptic compounding filling inspection and packaging activities. This role applies knowledge of cGMP and regulatory standards to review documentation monitor processes and support investigations. QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement SUMMARYThe QA Specialist I provides quality oversight and compliance support for operations including equipment and material preparation aseptic compounding filling inspection and packaging activities. This role applies knowledge of cGMP and regulatory standards to review documentation monitor processes and support investigations. QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement RESPONSIBILITIESReview and evaluate manufacturing and testing documentation to ensure compliance with SOPs and cGMP requirements applying professional judgment where quality oversight and guidance during shop floor activities inspection readiness and in-process checks including deviation and laboratory investigations change management SOP revisions and batch documentation and escalate quality issues and contribute to root cause analysis and corrective actions to maintain compliance with cross-functional teams to support process improvements and ensure adherence to regulatory requirements. Collect analyze and report departmental data to identify trends and support continuous improvement in training and mentoring QA colleagues sharing best practices to strengthen team the ability to understand and demonstrate proficiency in aseptic techniques and behaviors required in aseptic processing knowledge of manufacturing operations and quality procedures to proactively influence compliance issues identified during batch production or record reviews promptly to management demonstrating accountability and ownership of quality and edit SOPs logbooks and batch records for accuracy and regulatory in internal GMP audits and supports customer and regulatory in review and editing of SOPs / Master Batch ERP transactions as applicableMust 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 1 years experience in the Pharmaceutical or related industryThe 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