Coordinate and supervise inspection and release of plasma lots for sale or further manufacture
Verify critical systems and documentation associated with the destruction of plasma
Ensure compliance to approved procedures
Responsible for quality acceptance and release of plasma product shipments and supervision of daily activities of quality assurance staff
Supervise daily activities related to receipt, storage, processing of Lookback Alerts, quarantine of unsuitable units, and release of Source Plasma
Review and verify temperature documentation to ensure conformance to appropriate temperature specifications
Investigate and document deviations noted from compliance reviews, audits and customer complaints
Participate in writing and revising policies and procedures related to Source Plasma
Monitor Plasma Operations for compliance with regulations, cGMPs and CFRs
Participate in internal audit for the facility
Interface with multiple management levels and support/service groups internally and externally
Train current and new employees and maintain/update training records of QA staff
Supervise activities of quality assurance staff including hiring, performance management, and professional development
Monitor department costs to meet QA and company financial objectives

Bachelor’s degree in life sciences or related field ideal
Minimum of 5 years of Quality Assurance related experience
3 years working in pharmaceuticals
Project or technical leadership experience required
Supervisory or management experience preferred
Strong analytical, organizational and interpersonal skills
Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines
Excellent written/verbal/leadership skills
Ability to make sound decisions that may affect the quality purity or efficacy or a drug product
Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner.

Supervisor, Plasma Quality Assurance – 2nd Shift

Key skills