Quality Assurance Specialist

5 days ago


Morrisville, North Carolina, United States Hornet Staffing, Inc, a GEE Group company Full time

Description:

  • Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.
  • 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.
  • Obtaining Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
  • Reviewing and verifying all incoming documentation to confirm that materials meet defined testing specifications and quality standards.
  • Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
  • Archiving finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.
  • Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.
  • Complete assigned training and tasks within required timelines, represent the Quality function in cross-functional meetings, and provide feedback to the team as needed.
  • Provide quality oversight and compliance guidance in accordance with company procedures and standards outlined in the SMPA Quality Management System.
  • 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.
  • Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
  • This role is an on-site position, scheduled Monday through Friday, primarily supporting GMP operations. The standard working hours are from 8:00 AM to 4:00 PM; however, flexibility may be required based on business needs.

Qualifications :

  • B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
  • At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
  • Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
  • Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
  • Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
  • Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.
  • Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.
  • Working experience in KNEAT, SlingShot, SAP, Blue Mountain RAM and VEEVA is preferred.


  • Morrisville, North Carolina, United States Alliance Health Full time

    Under the general guidance of the Quality Management Director, the Manager of Quality Performance plays a central role in continuously improving Alliance's quality related strategies and innovation capabilities. The candidate must be a proven people developer with a collaborative approach that builds trust within internal and external stakeholders including...


  • Morrisville, North Carolina, United States Alcami Full time

    :At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.Are you interested in joining our team?Job Summary:The Sr. Manufacturing Specialist is accountable for driving...


  • Morrisville, North Carolina, United States Alliance Full time

    The Provider Network Evaluator I-Clinical Quality performs clinical quality reviews and plan of correction implementation reviews of service providers contracted with Alliance Health.  Additionally, in limited situations, Provider Network Evaluator I may investigate instances of concerns to ensure individuals receive sufficient, safe, and effective services...


  • Morrisville, North Carolina, United States Perdue Full time

    Perdue Foods has a goal of becoming the most trusted name in premium proteins by creating products for consumers and for retail and foodservice customers around the globe while changing the way animals are raised for food. It is part of Perdue Farms, a fourth-generation, family-owned food and agricultural business deeply rooted in tradition yet with a...

  • Leave Specialist

    6 days ago


    Morrisville, North Carolina, United States PRESTIGE EMPLOYEE ADMINISTRATORS Full time

    Company Overview: For more than 25 years, Prestige has provided cost-effective employee benefits and HR services, transparent pricing, and personalized, quality service to every client. We go the extra mile to develop long-term relationships and build strong partnerships with each client we serve. We help our clients focus on running—and growing—their...


  • Morrisville, North Carolina, United States bioMerieux Full time

    DescriptionThis position follows a hybrid work schedule. The selected candidate must be able to work onsite 2–3 days per week at one of the following designated office locations: Morrisville, NC; St. Louis, MO; or Salt Lake City, UT.Position SummaryPerform preventative maintenance fine tuning and spectral checks of assigned bioMérieux products/systems...

  • Data Entry Specialist

    2 weeks ago


    Morrisville, North Carolina, United States Syneos Health Full time

    DescriptionData Entry Specialist (Dallas, TX)Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience...


  • Morrisville, North Carolina, United States UNC Health Full time

    DescriptionBecome part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.This position works onsite at UNC Medical Center in Chapel Hill, NC.Summary:Supports physicians, clinicians, health care workers, affiliates and partners by providing continuous support,...


  • Morrisville, North Carolina, United States Syneos Health Full time

    DescriptionSharePoint Intranet Redesign SpecialistSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Every day we perform better because of how we work together, as one...


  • Morrisville, North Carolina, United States FujiFilm Full time

    Position Overview:The Specialist, Quality Control (QC) Sample Management is responsible for handling samples manufactured at the site, sample and reference materials from outside sources (e.g., drug products), and stability samples. This role ensures sample transactions are documented by performing entries into electronic systems (LIMS and FreezerPro) or via...