Our client is seeking a highly motivated and experienced Senior Quality Assurance (QA) Specialist who will play a critical role in supporting quality assurance activities related to the management of materials and consumables within the operational landscape. This individual will assist in overseeing the release of incoming materials, ensuring that they meet the necessary standards for internal manufacturing processes. Responsibilities span across reviewing essential documentation, managing quality systems, and supporting the analytical and manufacturing operations to ensure compliance and efficiency.
Essential Duties and Responsibilities (but not limited to):
Provide QA oversight and guidance for the release and management of raw materials and consumables for internal manufacturing operations.
Review and verify the integrity of Good Manufacturing Practice (GMP) documentation associated with incoming materials.
Conduct thorough reviews of executed documentation to ensure compliance with internal standards and regulatory requirements.
Confirm that all necessary documentation is complete and acceptable prior to the release of materials.
Assist with the daily management of processes involved in releasing materials and consumables.
Collaborate in the handling of Supplier Corrective Action Requests (SCARs) and assess their potential impact on materials release, supporting vendor investigations as required.
Maintain organized, up-to-date records of materials management documentation, ensuring easy retrieval and archiving.
Contribute to the preparation of regular quality system metrics and reports concerning material management activities.
Foster effective communication and collaboration with both internal teams and external stakeholders, escalating critical findings when necessary.
Qualifications:
Bachelor's degree in a scientific or healthcare-related field with 3-5 years of relevant experience, or an equivalent mix of education and professional background.
Demonstrated experience in supporting QA functions within a regulated manufacturing setting, particularly in materials management.
Proven success in managing SCARs and supporting vendor-related investigations.
Familiarity with systems such as Oracle, Laboratory Information Management Systems (LIMS), and document management platforms like Veeva.
Strong understanding of current Good Manufacturing Practices (cGMP) in regulated environments.
Experience working effectively in cross-functional team environments.
Ability to thrive in fast-paced environments while managing multiple priorities and timelines.
Exceptional attention to detail with a focus on maintaining high standards of quality.
Proficiency in both written and verbal communication, facilitating effective team collaboration.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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