Quality Assurance Specialist
$28 - $31 per hourSGS Consulting
1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by SGS Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $28.00/hr - $31.00/hr Direct message the job poster from SGS Consulting Recruiting Team Lead || US Staffing || Pharmaceutical, Clinical & Healthcare Industry || Description: Manager’s note: This is a supportive QA role focused on Review and approval of Solution lot records, reports, logbooks, and release of autoclaved equipment. The contractor will be supporting Large Scale Manufacturing. Please ensure candidates have a strong ethic and knowledge of cGMP in a Biomanufacturing field. 1+ years' experience would be amazing. RTP Onsite Duration: 6 Months The Quality Assurance Associate II (Contractor) is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Client Research Triangle Park (RTP) facility. Activities include but are not limited to a review of GMP raw data for compliance. The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers. Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition.
- Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.
- Supports resolution of both technical and compliance issues/gaps of mild to moderate complexity.
- Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by client.
- Complete and maintain related GMP training.
- Additional job duties that may be assigned from time to time.
- 0-2 years directly related to position responsibilities or biologic experience preferred.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Quality Assurance Specialist in Durham, NC vacancy
- ...Quality Assurance Specialist This position is responsible for providing QA oversight and auditing activities related to clinical and preclinical studies. Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal...SuggestedFlexible hours
LanceSoft
Durham, NC4 days ago - ...Senior Specialist, Quality Assurance The Senior Specialist, Quality Assurance provides Quality Assurance (QA) oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, GCP and GMP vendors. The role performs vendor assessments and audits, ensures compliance with...SuggestedLocal area
AskBio
Durham, NC11 hours ago - ...external regulatory standards and expectations into appropriate quality standards and provide mentorship to project teams or functions... ...with a focus on GMP studies Demonstrated knowledge of Quality Assurance activities, ICH regulations, and FDA/EU GxP regulations as they...Suggested
AstraZeneca
Durham, NC2 days ago - ...questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which... ...for others to build on via Science Foundry. The Quality Assurance Specialist will support efforts to ensure the quality and conformity of...SuggestedLocal areaShift work
- Precision BioSciences, Inc. is seeking a Quality Specialist III responsible for providing quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations. Key duties include batch release review, deviation assessments, and supporting regulatory compliance...SuggestedWork at office
- Quality Assurance Specialist II, Raw Materials Location: Durham, NC, US Company: oxfordbiom This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States. Responsibilities Lead risk assessments and author...
- Duke Clinical Research Institute is seeking a GMP, Quality Assurance Associate II to ensure compliance and quality in GMP programs. You will support the Marcus Center for Cellular Cures and play an important role in clinical research and patient-focused manufacturing. Ideal...
- Durham County Government is seeking a training specialist for the Family & Children’s Medicaid FEI program within DSS. The role designs... ...delivers training materials, mentors new hires, and performs 100% quality reviews of new hire work. You will monitor compliance with...Work at officeLocal area
- ...About the job Quality Assurance Specialist Quality Assurance Specialist needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations. Quality Assurance Specialist requires: 8a-4p cGMP...Work experience placementFlexible hours
Global Channel Management
Morrisville, NC3 days ago - Oxford Biomedica in Durham, North Carolina is seeking a Quality Assurance Senior Specialist to oversee operations in an FDA-approved clinical cGMP manufacturing facility. This role is critical in ensuring compliance and advancing our mission of delivering life-changing...
- ...project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The role will... ...industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality...Immediate startFlexible hours
- Retail Operations Job Food Lion has been providing an easy, fresh and affordable shopping experience to the communities we serve since 1957. Today, our 82,000 associates work in stores, distribution centers, and offices across the country. Food LionWork at office
- KBI Biopharma in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. This role includes reviewing test data, supporting client audits, and providing QA oversight of laboratory activities. The ideal candidate...
$86.71k - $140.13k
...Health System comprise Duke Health, a world‑class academic medical center. The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate II to join our team. In this role, you will help ensure that the products, materials, and...Work at officeShift work- oxfordbiom is expanding its US footprint and seeks a Quality Assurance Senior Specialist to lead cGMP-compliant operations in a clinical manufacturing setting in Durham, NC. The role ensures documentation integrity, batch disposition, and regulatory readiness across QA...
- Job Summary This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- process, and stability test data. The role also reviews and approves method qualifications and validations...
- ...Position Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant... ...Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor. Relationships...Local areaShift workAfternoon shift
- Duke University in Durham, North Carolina is seeking a GMP, Quality Assurance Associate II to help ensure compliance and quality in their GMP programs. In this role, you will work with various partners, supporting quality systems and continuous improvement efforts. The...
- Job Summary The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities...Work experience placementMonday to FridayDay shift
$113k - $156k
...laboratory deviations. The Principal QA Specialist provides exemplary service to both internal... ...goals. Cultivates and maintains Quality culture.May perform as a team lead for a... ...process, release, and stability samples. Assures activities comply with required procedures...Immediate start$86.71k - $140.13k
...Hospice, Duke Health and Wellness, and multiple affiliations. Be You. The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate II, to join our team. In this role, you will help ensure that the products, materials, and processes...Work experience placementWork at officeShift work- Precision BioSciences, Inc in Durham, NC is seeking a Quality Specialist III to provide dedicated quality assurance support for Chemistry, Manufacturing, and Controls operations. This role includes reviewing batch releases, performing deviation assessments, and ensuring...
$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....- BioSpace is seeking a Quality Assurance professional in Durham, NC to ensure compliance with regulations and approve quality documentation. The ideal candidate will have at least two years of QA experience, preferably in the pharmaceutical industry, and excellent communication...
- ...Position Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant... ...Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor. Relationships...Local areaShift workAfternoon shift
- 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...
- Novo Nordisk A/S in Durham, North Carolina seeks a Quality Assurance professional to ensure compliance with regulations and internal standards. The role involves documentation review, root cause analysis, and participation in audits. Candidates should have at least two...
$113k - $156k
KBI Biopharma Inc. in Durham, NC is seeking a Principal QA Specialist responsible for compliance review of Biopharmaceutical GMP data. You will provide QA oversight of various laboratory activities and ensure patient safety and regulatory compliance. The ideal candidate...$35.87 - $51.57 per hour
...Level I Adult & Pediatric Trauma Center, utilizing data‑driven quality improvement strategies to enhance patient outcomes and... ..., reporting, and regulatory initiatives. A clinical quality assurance specialist uses a combination of nursing, quality, and informatics knowledge...Hourly payFlexible hours- ...deviations, CAPAs, and investigations. You will collaborate with QSU and sponsors, prepare deviation reports, support inspections, and educate staff on quality plans while driving continuous process improvements under the GMP Compliance unit. #J-18808-Ljbffr Duke University
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Specialist. Be the first to apply!
