Quality Operations Technician 1

States considered:

Role Description:

The Quality Operations Technician supports the management of raw materials and drug products storage for stability studies and retains. This role is critical to the management of stored inventory, timely Quality Control testing of stability batches, and compliance reporting of stability data.

RESPONSIBILITIES:

• Oversee the creation and revision of stability study protocols, reports, SOP's, and quality stability records compliant with ICH guidelines and other regulatory expectations.
• Reviews and approves completed stability reports.
• Develop cross-functionally and oversee execution of stability protocols.
• Determine stability sample requirements.
• Coordinate, receive and organize samples for stability studies.
• Manage APR reporting, specification, stability data entry and all associated trending.
• Initiate stability studies including necessary documentation, initiation in stability database, choosing appropriate locations within chambers, and charging samples into the chambers.
• Drive investigations related to out of specification or out of trend results, as necessary.
• Manage and archive the cGMP stability documentation.
• Participate in FDA/Regulatory/Client audits as necessary.
• Track, trend, and report on key quality stability performance indicators and deliverables.
• Provide additional support to the QC/QA team as determined by the QC/QA Manager.
• Work with other departments to develop and manage short-term stability studies on lab scale and engineering batches to support formulation and process development.

QUALIFICATIONS:

• AAS or BA/BS in Chemistry, Microbiology, Biology, or related science preferred. Other degrees considered with significant QA/QC or science aptitude.
• Previous QA/QC experience in a GMP Pharmaceutical manufacturing environment desired. MS Office, Excel, MiniTab, SAP, LIMS systems experience/proficiency desired.
• NOTE: Candidate must not be cephalosporin/penicillin sensitive

Full timeRegularColleague

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