Quality Assurance Associate
The Associate, Quality Assurance is responsible for creating and maintaining current specifications, addressing change controls for specification updates, working with quality metrics, SOPs, deviations, CAPA to assist with ensuring the site is in compliance with SOPs and regulatory requirements. Is a back-up for other responsibilities to ensure proper staffing to meet departmental timelines.
- Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions.
- Create, manage, and/or implement change controls for various activities.
- Creation or review of quality metrics for monthly Quality Review Board meetings. Ensure metrics are met for items personally responsible for.
- Knowledge of deviation and CAPA system – able to perform investigation and root cause analysis.
- Participate in internal audits and regulatory inspections as required.
- Creation and revision of SOPs utilizing an electronic system.
- Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site. Knowledge of LIMS and Oracle systems.
- Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities.
- Bachelor degree in Life Sciences
- Minimum 5 years of Quality Assurance experience in the pharmaceutical industry
- Knowledge of sterile operations preferred.
- Knowledge of cGMPs and GLPs
- Demonstrated effective communication and interpersonal skills across multiple departments.
- Strong organizational skills