34133 QA Compliance Associate/Sr. Associate Weekday ...

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. Our Promise: Caring, Sharing, Growing We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources. Shift: Monday - Thursday Nights - 6pm - 4:30am Job Description: The QA Compliance Associate/ Sr. Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. Essential responsibilities include: Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations. Accountable for facilitating Deviation investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval. Enters data into database in support of the corporate RCA and CAPA activities. Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks. Interface with management and responsible individuals to assure task completion on or before established due dates. Responsible for supporting quality systems, processes and procedures (e.g. Deviation, CAPA, Vendor complaint, etc) to assure compliance and product quality and safety. Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections. Provide Deviation and CAPA metrics as needed in support of management review of system data. Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents. Sr. Associate (In addition to above) Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company. Speak to assigned deviations during regulatory and client audits. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate) Perform special assignments as directed by the supervisor. Qualifications: Associate: Associates Degree in Biology, Chemistry or related field required. OR 5 years of experience may be used in a lieu of an Associate's degree. Bachelor's Degree in a science field desired. Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience. Pharmaceutical and FDA regulated industry experience de

Created: 2024-10-27