Position Summary: The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations. Position Responsibilities: Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records Support Manufacturing changeover process Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner Author, review, and approve deviation investigations Support client batch record review process Support QA Raw Material group with release of raw materials as needed Able to react to change productively and handle other essential tasks as assigned. Position Requirements: QA Specialist I: Bachelor’s degree and 2 years of experience QA Specialist II: Bachelor's degree and 6 years of experience Experience in a cGMP QA environment or equivalent is preferred. Salary: $67,000 - $85,000 This is a night shift position and will be eligible for a shift differential in addition to base salary. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently. Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.

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1 Jul, 2024

Jsrglobal

Facilities CMMS & Spare Parts Coordinator

USA - NC - Durham - National Way, United States of America

Salary not listed

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