Manufacturing QA Specialist II - Real-Time Quality Lead
KBI Biopharma, Inc.
KBI Biopharma, Inc. is seeking a Manufacturing Quality Assurance (MQA) Specialist to support GMP manufacturing operations. This role involves providing real-time guidance, leading compliance reviews, and collaborating with cross-functional teams to meet regulatory requirements. The ideal candidate will have 1-3 years of experience in a GMP environment and possess strong communication skills, with preference for candidates holding an associate or bachelor's degree. Salary range is $55,000–$86,900 with a 12-hour shift pattern for continuous coverage. #J-18808-Ljbffr KBI Biopharma, Inc.
- ...differential.Job SummaryThe QA Manufacturing Specialist is responsible for ensuring... ...documentation, and systems conform to quality standards, internal... ...other compliance issues in a timely mannerSupport client audits... ...RequirementsMQA Specialist II: BS/BA in scientific field and...QualityWork at officeImmediate startShift workNight shift
$55k - $86.9k
Job Summary The Manufacturing Quality Assurance (MQA) Specialist supports the manufacturing process... ...The specialist provides real‑time guidance to manufacturing... ...logbooks, and internal records. Lead deviation determination,... ...for MQA Specialist II (4-6 years experience). Expect...QualityContract workShift work- KBI Biopharma is looking for a QA Manufacturing Specialist responsible for ensuring product quality and compliance with regulations and internal procedures. This position provides oversight for bulk drug substance manufacturing activities and requires experience in a GMP...QualityNight shift
$55k - $86.9k
KBI Biopharma in Durham, NC, is looking for a Manufacturing Quality Assurance Specialist, responsible for supporting the Manufacturing process in a dynamic GMP environment. The role requires real-time guidance to Manufacturing teams, ensuring compliance with standards....Quality- ...biopharmaceutical development and manufacturing, we empower life... ...:Responsible for leading technical support... ...initiatives, compliance & quality requirements.Responsibilities... ...industry experience.Specialist II: High School Diploma... ...my employment at any time and for any reason,...QualityContract workWork at officeImmediate start
- ...opportunity to help improve the quality of life for millions of... .... What we offer you: Leading pay and annual... ...employees enjoy generous paid time off including 14 paid... ...with LoB) & QA presence & process confirmation... ...Understanding of cGMP manufacturing & production processes...QualityLocal areaShift workNight shift
- ...Job Description 7PM-7AM / 2*2*3 Manufacturing Schedule The Manufacturing Associate I/II - Nights will perform Upstream or... ...records while ensuring compliance with quality standards, company policies, and... ...Practices (GDP) at the time of execution. Ensure proper issuance...QualityShift workNight shift
$24 - $31.25 per hour
...position is on a 2-2-3 shift, 6p-6a. The Manufacturing Associate I/II - Downstream is responsible for the... ...per batch records in compliance with quality standards, company policies, and regulations... ...(SR, ERP, BR) following GDP at the time of execution. Ensure all materials and...QualityHourly payShift workNight shift- Manufacturing Associate I/II- (Nights) page is loaded## Manufacturing Associate I/II- (Nights)locations:... ...records while ensuring compliance with quality standards, company policies, and current... ...Documentation Practices (GDP) at the time of execution.* Ensure proper issuance...QualityImmediate startShift workNight shift
- Initial Therapeutics, Inc. is seeking a Quality Assurance professional based in Durham, North Carolina. This role involves ensuring compliance... ...'s degree in life sciences and at least three years of relevant QA experience in a pharmaceutical environment. #J-18808-Ljbffr...Quality
- KBI Biopharma, Inc. is seeking an individual contributor for a Quality Assurance role focused on compliance with regulatory guidelines. This position involves interfacing with clients regarding batch status, managing quality issues, and ensuring systems are effective and...Quality
- A leading biopharmaceutical company located in Durham, NC, is seeking a Manufacturing Associate I/II for their 12-hour night shifts. This role involves performing upstream or downstream... ...environment, ensuring compliance with quality standards. The ideal candidate must...QualityNight shift
- KBI Biopharma in Durham, North Carolina is seeking Manufacturing Associates I/II for Solution Prep. This role involves performing upstream or downstream... ...activities in compliance with GMP standards, focusing on quality and accuracy. Candidates should have a Bachelor’s degree...Quality
- ...Sterile Processing Technician, Lead assists the OR staff in... .... Acts as HLD Specialist. Performs/assists with daily quality testing on equipment in SPD... ...processed and ready in a timely manner. SPM/Quality... ...tray errors. Performs real time in-services with SPD...QualityImmediate startMonday to FridayFlexible hoursShift workNight shiftWeekend work
$86.71k - $140.13k
...of Regulatory Affairs & Quality (ORAQ) is seeking a GMP... ...Control Associate II to join our team. In this... ...will work closely with Manufacturing, Product Development, and... ...leadership Experience leading laboratory investigations... ...organizational and time management skills with...QualityWork experience placementWork at office- ...environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in‑process, and stability).... ...basic algebra/statistics skills. Ability to sit for long periods of time and lift up to 20 pounds. Proficiency with word processing,...
- Position Summary Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product,... ...Lean Manufacturing. Requirements Specialist I: High School Diploma with 5+ years... ...industry experience. Specialist II: High School Diploma with 8+...
$24 - $31.25 per hour
...This role is a night‑shift position on a 2‑2‑3 schedule. The Manufacturing Associate I/II performs upstream or downstream processing of bulk... ...written, approved procedures and forms to ensure Right First Time (RFT) manufacturing under Good Manufacturing Practice (GMP)...Hourly payShift workNight shift- KBI Biopharma in Durham, North Carolina, seeks a Specialist for GMP Manufacturing Operations. You will lead technical support activities, draft batch records, and... ...field. Join us to empower life science companies and make a real impact. #J-18808-Ljbffr KBI Biopharma
- ...Deviations and CAPAs in support of GMP manufacturing operations. Support timely review of events for classification,... ...and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and... ...or equivalent. Experience with Quality Systems to include Batch Record review...Quality
- Join Novo Nordisk in Durham, NC as a Quality Assurance professional, responsible for ensuring... ...quality standards in our pharmaceutical manufacturing operations. The ideal candidate will... ..., including health insurance and generous paid time off. #J-18808-Ljbffr Merck & Co.Quality
$113k - $156k
...test data. The Principal QA Specialist provides QA oversight... ...lifecycle activities for timely delivery of products to... ...clients, laboratories, manufacturing, QA batch disposition,... ...and maintaining a quality culture. It may also serve as a team lead for specific responsibilities...Quality- ...compliance with internal quality documents, regulatory... ...team, reporting cross-QA metrics and status for... ...guidelines governing the manufacture and holding of materials... ...accountable Quality lead, decision maker, and delegate... ...tasks, manage time effectively. Positive proactive...QualityFlexible hours
$113k - $156k
...test data. Provides QA oversight of... .... The Principal QA Specialist provides exemplary... ...lifecycle activities for timely delivery of products... ...clients, laboratories, manufacturing, QA batch... ...Cultivates and maintains Quality culture. May perform as a team lead for a specific responsibility...QualityImmediate start- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations... ...and CAPAs in support of GMP manufacturing operations. Support timely review of events for... ...Biopharmaceuticals or equivalent. Experience with Quality Systems to include Batch Record...QualityImmediate start
- ...of Deviations and CAPAs to support GMP manufacturing operations. This position involves collaborating... ...and providing mentorship to junior QA staff. The ideal candidate will possess... ...emphasizing a strong grasp of relevant quality systems and regulations. #J-18808-Ljbffr...Quality
- What we offer you: Leading pay and annual performance bonus for all... ...employees enjoy generous paid time off including 14 paid holidays... ...Records (BPRs) and/or relevant quality processes are compliant with... ...business (LoB)), Quality Assurance (QA) presence & process...QualityLocal areaShift workDay shift
$28 - $31 per hour
...Recruiting Team Lead || US Staffing |... ...is a supportive QA role focused on... ...supporting Large Scale Manufacturing. Please ensure... ...: 6 Months The Quality Assurance Associate II (Contractor) is... ...assigned from time to time. • 0-2 years... ...Assurance Specialist jobs in Durham,...QualityContract workFor contractorsRemote workNight shift- ...biopharmaceutical development and manufacturing, we empower life science... ...regulatory audit readiness at all times* Participates in data review... ...’ experience. QC Analyst II requires Bachelor’s degree as... ...commercial products. Recognized for quality manufacturing, KBI delivers...QualityFull timeContract workImmediate start
- Job Description Client: Direct Client Location: Research Triangle Park, NC Job Title: Quality Control Associate II Duration: 1 Year+ Primary Responsibilities The execution of QC routine testing to include TOC, conductivity, and nitrates. Executing TOC method validations...Quality
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