KBI: US - Principal QA Specialist
$113k - $156kKBI Biopharma
Position Summary This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients, laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture. May perform as a team lead for a specific responsibility listed below, in which case, the approximated amount of time will be skewed toward the specific responsibility. Position Responsibilities Performs timely review of test data for in process, release, and stability samples. Assures activities comply with required procedures, cGLP, and cGMP requirements. Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing. Provides QA support for deviations, CAPAs, laboratory investigations, change controls and projects related to laboratory processes, instruments, specifications, methods and SOPs. Attends relevant operational meetings in support of manufacturing operation, analysis and disposition activities. Supports client audits and regulatory inspections as required. Other activities as assigned by Management. Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals. Serves as trainer/mentor for QA specialists and cross-trainer for employees in other departments to support individual development goals. Minimum Requirements Bachelor’s degree and 10+ years’ experience or Master’s degree and 6+ years’ experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolution skills. Strong understanding of FDA, EU and cGMP regulations is required. Experience in quality control and quality systems is beneficial. Salary: $113,000-$156,000 EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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. #J-18808-Ljbffr KBI Biopharma
- ...and cGMP. The role will serve as Quality-to-Quality client liaison and sometimes SME for the Quality team reporting cross-QA metrics and status for KBI and clients. The role is client-facing. The role will be responsible for supporting processes required for product...PrincipalImmediate startFlexible hours
- ...for a shift differential.Job SummaryThe QA Manufacturing Specialist is responsible for ensuring raw... ...or equivalent is required.Knowledge of US and EU cGMP guidelines/regulations is desired... ...single-use platform technology is preferred.KBI Biopharma, Inc. is an EEO/AA employer...SuggestedWork at officeImmediate startShift workNight shift
- Principal Quality Compliance Specialist Deviations and Client SupportSkip to main contentOur website... ...closure. Mentors junior QA staff in deviation/CAPA... ...Deviation and CAPA TRNs to KBI staff.* Collaborate with functional... ...and CAPAs. Knowledge of US, EU and Row cGMP guidelines...PrincipalImmediate start
$99.14k - $136.32k
...vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs. EEO Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants, regardless of race, color...SuggestedTemporary workWork at office- KBI Biopharma is looking for a QA Manufacturing Specialist responsible for ensuring product quality and compliance with regulations and internal procedures. This position... ...degree and relevant experience, particularly with US and EU cGMP guidelines. The role involves supporting...SuggestedNight shift
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...and holidays, 401(k) with rapid vesting, sabbatical eligibility, and employee recognition programs. EEO & Equal Opportunity Statement KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless...Work at office- KBI Biopharma in Durham, North Carolina is seeking a qualified candidate for a position responsible for the compliance review of biopharmaceutical development GMP data. This includes overseeing release, in-process, and stability test data, method qualifications, and laboratory...
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...from SGS Consulting Recruiting Team Lead || US Staffing || Pharmaceutical, Clinical &... ...Description: Manager’s note: This is a supportive QA role focused on Review and approval of... ...Get notified about new Quality Assurance Specialist jobs in Durham, NC . REMOTE - Quality...Contract workFor contractorsRemote workNight shift- ## Principal Scientist, DeliveryApplyremote type: Onsitelocations: Durham, NCtime type: Full timeposted on: Posted 2 Days Agojob requisition... ...to express interest in a specific opening by calling us at (***) ***-**** or sending us an email at ****@*****.***.*...PrincipalLocal area
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A leading digital consultancy is seeking an experienced Associate Principal, CX Application Strategy, to drive digital transformation initiatives. In this hybrid role based in Durham, NC, you will lead efforts in enhancing customer experience through AI and technology integration...Principal- CHURCHILL HOUSE VIP EVENTS in Durham, NC, is seeking an Assistant Principal dedicated to fostering vibrant school communities and driving academic excellence. This role involves observing and coaching teachers, developing relationships with students and families, and ensuring...Principal
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Sr. Principal Regulatory Medical Writer - Oncology Preferred Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108891-... ...and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment...PrincipalContract workFlexible hours- A leading biotechnology company in North Carolina is looking for a Sr QA Specialist to enhance their Quality Management System. The ideal candidate will ensure compliance with regulations, support audits, and engage in continuous process improvement. Candidates should hold...Full time
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