Planet Pharma
Specialist QA I - Manufacturing Oversight
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Specialist QA I - Manufacturing Oversight
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Planet Pharma . Get AI-powered advice on this job and more exclusive features. Job Description
The
QA Specialist I - Manufacturing Oversight
performs manufacturing oversight activities to ensure compliance with policies and procedures. Responsibilities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor. Qualifications
Essential Duties: Understanding of Quality Systems (e.g., Deviations, CAPAs, Change Controls, OOSs). Perform QA review and approval of Event notifications. Knowledge of cGMP and regulatory compliance (e.g., 21 CFR Parts 11, 210, 211, 600). Oversee and inspect active production areas for compliance and problem resolution. Supervise Buildings 1 and 2, including cold rooms/freezers. Review and release Plasma pools and manufacturing support documentation. Review and release raw materials in LIMS/SAP. Audit Nitrogen receipt processes. Assist with quarantining and releasing critical systems, equipment, and environments. Participate in rotation for 24/7 manufacturing oversight, working 12-hour shifts and supporting either shift as needed. Support additional oversight activities and projects assigned by QA Management. Experience with LIMS and SAP is preferred. Education:
Bachelor's Degree preferred, experience can offset. Experience:
1-3 years in pharmaceutical, biotech, or related industry preferred. Planet Pharma is an equal opportunity employer committed to diversity and inclusion.
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Join to apply for the
Specialist QA I - Manufacturing Oversight
role at
Planet Pharma . Get AI-powered advice on this job and more exclusive features. Job Description
The
QA Specialist I - Manufacturing Oversight
performs manufacturing oversight activities to ensure compliance with policies and procedures. Responsibilities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor. Qualifications
Essential Duties: Understanding of Quality Systems (e.g., Deviations, CAPAs, Change Controls, OOSs). Perform QA review and approval of Event notifications. Knowledge of cGMP and regulatory compliance (e.g., 21 CFR Parts 11, 210, 211, 600). Oversee and inspect active production areas for compliance and problem resolution. Supervise Buildings 1 and 2, including cold rooms/freezers. Review and release Plasma pools and manufacturing support documentation. Review and release raw materials in LIMS/SAP. Audit Nitrogen receipt processes. Assist with quarantining and releasing critical systems, equipment, and environments. Participate in rotation for 24/7 manufacturing oversight, working 12-hour shifts and supporting either shift as needed. Support additional oversight activities and projects assigned by QA Management. Experience with LIMS and SAP is preferred. Education:
Bachelor's Degree preferred, experience can offset. Experience:
1-3 years in pharmaceutical, biotech, or related industry preferred. Planet Pharma is an equal opportunity employer committed to diversity and inclusion.
#J-18808-Ljbffr