Quality Systems QA Manager

Scientific Protein Laboratories•Waunakee, WI

7d•Onsite

About The Position

Responsible for management of the sites Quality Systems including but not limited to cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate and finished product, review/coordination of investigations (including customer complaints), approval of deviations, change controls, and CAPAs; approval of validation/qualification documents; hosting of external agencies and/or customer audits. The manager is responsible for personnel activities such as: reviews, workload management and coordination of training.

Requirements

Associate's Degree, Bachelor's Degree or above preferred
10+ years of experience, 15+ years preferred

Responsibilities

Responsible for the functions associated with the Quality System, including oversight and coordination of training, investigations (including customer complaints), deviations, change controls, CAPAs and validation/qualification documents.
Oversee the establishment/maintenance of relevant procedures/documents
Compiles and communicates metrics associated with the Quality System to management as required.
Administer and oversee the electronic quality management system (eQMS).
Responsible for continuous improvement of SPL cGMP Quality Systems to support compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
Oversee external agency and customer audits, and responses to audit findings.
Performs intermediate and finished product release, and shipping documentation review/approval.
Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.
Writes customer related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)
Oversee the investigation of process deviations, product failures, customer complaints or facility incidents and assures proper documentation and investigation per established procedures.
Approves minor deviations and related CAPAs.
Participates in the Material Review Board including assessment of customer complaints.
Participates in assigning and addressing all customer communications.