Quality Assurance Floor Support Specialist
4 days ago
At BioSpace, Inc., we are dedicated to delivering innovative medicines to patients around the world. We are seeking a highly skilled Quality Assurance Floor Support Specialist to provide QA oversight to GMP operations at our new manufacturing site in Concord, North Carolina.
Responsibilities:
• Provide QA support of the startup, commissioning, and qualification of the Concord site.
• Collaborate cross-functionally with various levels of the organization to ensure seamless operations.
• Troubleshoot and provide support to resolve issues in quality systems such as SAP, LIMS, Trackwise, and MES.
• Maintain open communications and promote teamwork in the process team.
• Support the execution of inspection readiness activities, including support of site self-inspections.
Requirements:
• Knowledge of cGMP practices, including good documentation practices, data integrity, and regulatory compliance.
• Strong attention to detail and ability to work independently with minimal supervision.
• Proficiency with computer systems, including Trackwise, SAP, and other relevant software.
• Ability to work a 12-hour night shift on a rotating 2-2-3 schedule and overtime as required.
Education Requirements:
• High School diploma or equivalent.
• Associate's degree in a science, engineering, computer, or pharmaceutical-related field of study is preferred.
Additional Skills/Preferences:
• Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management.
• Previous experience with Manufacturing Execution Systems.
• Previous technical writing experience.
Why Join Us:
At BioSpace, Inc., we are committed to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. We offer a range of employee resource groups to support our diverse workforce and help develop talented individuals for future leadership roles.
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