Quality Associate II

About Prolacta Bioscience

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world’s leading hospital provider of 100% human milk– based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care. For more information, please visit www.prolacta.com.

Responsibilities

• Understand quality procedures, safety procedures and cGxP procedures and systems.
• Conduct cross functional training for any applicable departments.
• Support investigations for donor lookbacks, recalls and perform annual mock recall activities.
• Identify and update procedures that require corrections or updates.
• Review and may approve the following records in the quality system: CPAs, CSRs, LIRs, ORs, NCs, CAPAs, PCs, Risk Assessments, Planned Deviations and CCRs.
• Identify and assess regulatory and quality risks in operations according to applicable regulations and company quality practices. This could include on floor observations and support.
• Communicate and report product quality problems in the production lines or anywhere in the facility to appropriate personnel.
• Write and provide technical review for observation reports (OR), nonconformance (NC) or CAPA investigations and determine effective corrective actions.
• May work with suppliers on supplier issues, and completion of supplier corrective action report (SCAR).
• Review preventative maintenance forms.
• Support annual product review initiatives.
• Support recalls / field corrective actions.
• Support non‑medical and medical product complaints.
• Make interpretations of data generated and communicating the significance of these results to Quality Management.
• Review and support the change control process. This may include reviewing Change Plans and processing tasks and extensions.
• Lead or participate in risk assessments.
• Interface with the Manufacturing Enterprise System and conduct Quality tasks.
• Identify, lead and support continuous improvement initiatives (i.e. kaizens, just do it projects, etc.).
• Quarantine incoming raw materials and review for manufacturing release.
• Perform/assist with internal/external GMP audits.
• Prepare Quality Metrics report for Monthly/Quarterly meetings and gather weekly metrics data.