What are the responsibilities and job description for the Associate, QA Frontline position at TALENT Software Services?
We are seeking a dedicated professional to provide quality assurance oversight and support to our manufacturing operations. This role primarily involves night and weekend shift hours, with some flexibility required depending on operational demands. Key responsibilities and qualifications include:
- Provide on-the-floor QA oversight and support to manufacturing operations.
- Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.
- Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.
- Represent QA in support of deviations, including active participation in Root Cause Analysis (RCA).
- Provide cGMP and compliance guidance to Manufacturing and Technical Services personnel.
- Provide QA support, including authoring, review, and approval of documents in Quality Management Systems according to company policies.
- Perform area walkthroughs.
- Perform other duties and projects as assigned by management.
- Prior batch record execution or review experience.
- Prior experience in investigation, change control, and other Quality Management Systems (QMS).
- Working knowledge of cGMPs.
- Excellent written and verbal communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Experience in Manufacturing and Manufacturing Sciences preferred.
