Quality Assurance

Shift: 2:30 PM to 11:00 PM

Starting Pay Range: $18 DOE

JOB DESCRIPTION:
The Quality Assurance Inspector holds responsibilities encompassing oversight of manufacturing processes, compounding, batch record review, and release. This role involves investigating discrepancies, reviewing in-process material records, and assisting in the maintenance of records for the Quality Assurance Group. Upholding Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as supporting and preparing documentation for customer and regulatory audits, form integral components of this position.

PRIMARY DUTIES:
• Evaluate production batch records and related data to ensure compliance with cGMP regulations, reporting any deviations.
• Offer support for various quality functions and address potential issues.
• Aid in composing detailed reports and conducting analysis of quality data.
• Develop, revise, and scrutinize Standard Operating Procedures (SOPs) to maintain document accuracy.
• Generate and review cGMP labels, overseeing label generation reconciliation.
• Administer change control and training programs, managing Change Control packages.
• Handle issuance, filing, and distribution of company-controlled documents, updating SOP manuals and content indexes.
• Maintain accurate documentation, including manufacturing, quality control, and validation packages.
• Allocate batch lot numbers for diverse drug and medical device products.
• Validate and release printed materials (labels and unit cartons) for precision.
• Update documentation databases as necessary.
• Responsibilities extend beyond those mentioned above.

REQUIRED SKILLS AND QUALIFICATIONS:
• Adherence to existing and new regulations and compliance with company policies and procedures.
• Team-oriented mindset with a focus on customer results.
• Compliance with all safety policies and procedures to ensure a secure work environment.
• Flexibility for accommodating varying shifts and overtime to support manufacturing.

QUALIFICATIONS:
• Proficiency in Microsoft Excel, Microsoft Word, Microsoft Dynamics GP, and File Maker Pro for effective data management.