Job Description

Job Description

Job Description

This position is an excellent opportunity for a quality-minded individual wanting to have an impact in a technology-based pharmaceutical manufacturing company. You will be collaborating with other members of the QA team in coordination with other departments to help ensure that our products maintain the highest product quality.

Essential job functions include:

• Obtain and maintain ISO gowning certification for access to the aseptic areas (ISO 5 and ISO 7 Classified Areas).
• Provide quality oversight over each stage of the manufacturing of sterile injectable drug products. Such as equipment/component prep, formulation, aseptic set-up/filling, sealing, and inspection/labeling/packaging. Collaborate and provide guidance to production personnel during manufacturing to address quality issues and ensure compliance with policies and procedures and support company objectives.
• Review/approval of various GMP documentation.
• Support facility environmental requalification activities; review and compile test data supporting the formal release of the manufacturing facility for operational use.
• Support overall organizational cGMP compliance by identifying and implementing improvements.
• Support the quality management system as well as company initiatives/goals for various projects as assigned.

Attributes for the position:

• Requires a motivated individual, effective in working in teams, also able to make independent decisions.
• Must exhibit an elevated level of integrity and attention to detail.
• Effective written and oral communication skills and basic computer familiarity are required.
• Experience in Quality Assurance or FDA regulated, or ISO (classified) manufacturing environment is preferred.
• Bachelor’s degree in a Science related discipline. An equivalent level of experience may be considered if the applicant does not have a degree.

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