Biotech QA Specialist
Globalchannelmanagement
Overview QA Specialist (Biotech) needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations. Qualifications Pharma, Biotech industry Veeva cGMP manufacturing environment FDA Kneat Slinshot SAP Blue Mountain RAM Knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry Degree in Chemistry, biology or other Responsibilities Responsible for performing inspection and disposition of raw materials and components by: Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures. Get Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification. Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures. Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures. #J-18808-Ljbffr Globalchannelmanagement
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Biotech QA Specialist in Morrisville, NC vacancy
- A leading biotech company in Morrisville, North Carolina, is looking for a Quality Assurance Specialist to oversee manufacturing quality and compliance for commercial and investigational products. The role requires 3 years of experience in the biotech or pharmaceutical...SuggestedFull timeMonday to Friday
- ...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...SuggestedFull time
BioSpace, Inc.
Morrisville, NC4 days ago - Beam Therapeutics is looking for a Sr. Specialist I in NC Product Quality Assurance to oversee laboratory and manufacturing operations... ...alongside over 10 years of experience in the pharmaceutical or biotech industry. Responsibilities include Quality oversight of manufacturing...SuggestedFlexible hours
- Overview Join to apply for the Sr QA Specialist role at BioSpace . The Senior Specialist, Quality Assurance Laboratory Operations leverages skill in efficient, regulation-adherent processes, assessments, and process improvements to further improve quality functions, formalized...SuggestedFull time
- Alcami Corporation in Morrisville is seeking a Senior Quality Assurance Specialist. This role is responsible for ensuring quality and compliance with regulatory requirements and will include activities such as performing internal audits, maintaining quality databases,...SuggestedFull timeAfternoon shift
- 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...
- Cardinal Health in Raleigh, North Carolina is seeking a Senior Specialist, Quality Assurance to execute quality programs, policies, and procedures in areas such as recalls and customer complaints. This role minimizes risks and drives supply chain integrity while mentoring...
- ALOIS Solutions is seeking a Quality Assurance Specialist based in Durham, NC. The role involves managing the Quality Management System (QMS), ensuring compliance with GMP regulations, and providing support for QMS-related requests. The ideal candidate will have a Bachelor...
- ...requirements, 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...Immediate startFlexible hours
- Join Novo Nordisk in Durham, NC as a Quality Assurance professional, responsible for ensuring compliance with regulations and quality processes. This role involves reviewing documentation, supporting investigations, and conducting audits to maintain high-quality standards...
- A manufacturing company in Cary, North Carolina, seeks a Quality Specialist to ensure that all manufactured parts meet quality standards with minimal waste. You will collaborate with design and production teams, conduct inspections and audits, and manage the quality management...
- Senior QA Specialist Deviations and CAPAs page is loaded## Senior QA Specialist Deviations and CAPAslocations: USA - NC - Durham - Hamlin Rdtime type: Full timeposted on: Posted Yesterdayjob requisition id: R00008365Job Summary:Responsible for review and approval of Deviations...Immediate start
- OXB is seeking a Senior Specialist in Quality Assurance based in Durham, NC. In this role, you will be responsible for overseeing the compliance within an FDA-approved facility and ensuring quality in all operations. Ideal candidates will bring at least 7 years of experience...
- ...& approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) & QA presence & process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation...Local areaShift workNight shift
- ...EtQ and closure. Support external client review and resolution of comments for assigned deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as...
- ...years experience or MS with 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in‑process, and stability). Experience in reviewing method qualifications/validations and...
- 247Hire in Raleigh, North Carolina seeks a Senior Business Analyst / Tester for a hybrid role that integrates business analysis with software quality assurance testing. The successful candidate will work with stakeholders to document requirements and workflows, ensuring...
- FUJIFILM Holdings America Corporation is seeking a Senior QA Technical Specialist to provide quality assurance subject matter expertise in the GMP domain. The role involves reviewing validation and qualification documentation as well as supporting audits related to computerized...
- Merck in Raleigh, NC is seeking a Quality Assurance professional to lead audits and ensure compliance with global regulatory requirements. This role involves conducting audits, analyzing data, and collaborating with teams to uphold quality standards. The ideal candidate...Remote job
- ...expertise and proven regulatory track record. Are you interested in joining our team? 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...Full timeWork experience placementMonday to FridayAfternoon shift
- ...oversight on the shop floor, and support investigations. This role requires a Bachelor's degree in life sciences and at least three years of QA experience in the pharmaceutical industry, with strong communication skills and knowledge of cGMP. We offer competitive pay, generous...
- 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 will...
- ...critical documentation, and supporting the quality process on the shop floor. The ideal candidate will have a Bachelor's degree in life sciences and at least three years of relevant QA experience in a pharmaceutical environment. #J-18808-Ljbffr Initial Therapeutics, Inc.
$55k - $86.9k
Job Summary The Manufacturing Quality Assurance (MQA) Specialist supports the manufacturing process within a rapidly expanding GMP contract manufacturing organization. The specialist provides real‑time guidance to manufacturing, collaborates with cross‑functional teams...Contract workShift work$113k - $156k
...approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities... ...laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external...Immediate start- North Carolina State University is seeking a Quality Assurance professional to manage quality processes within the ACT facility. This role requires a Bachelor's degree in a scientific discipline and 2-3 years of relevant experience in a regulated manufacturing environment...
- 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 manufacturing environment...Work experience placementFlexible hours
- 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...
- ...consulting firm located in North Carolina is looking for an experienced Quality Assurance professional. The role involves providing QA support to manufacturing processes, reviewing, and approving critical documentation. Candidates should have a Bachelor's degree and over...
- ...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 skills. This position involves supporting...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Biotech QA Specialist. Be the first to apply!
Related searches
- vp biotech Morrisville, NC
- director biotech Morrisville, NC
- biotech Morrisville, NC
- pharmaceutical biotechnology Morrisville, NC
- biotechnology Morrisville, NC
- quality assurance assistant Morrisville, NC
- quality assurance Morrisville, NC
- director quality assurance Morrisville, NC
- qa testing Morrisville, NC
- pharmaceutical quality assurance Morrisville, NC