Manager, Plasma Quality Assurance

GRIFOLS, S.A.•Clayton, NC

5d•Onsite

About The Position

The Quality Assurance (QA) Manager assures consistent quality of production by developing and enforcing good manufacturing practices (cGMP) systems to ensure overall compliance with operating procedures, regulatory requirements and reports the facility compliance status to Operational and Quality management. This position has primary responsibility for the quality acceptance and release of plasma product shipments and manages the daily activities of the Plasma Logistic Center (PLC) quality assurance staff.

Requirements

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.
Must be able 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.
Displays a commitment to quality in terms of people, product and processes.
Computer literate, with experience in use of Microsoft applications.
BS degree in Biology, Chemistry or related Science or Engineering.
Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred.

Nice To Haves

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Responsibilities

Manages the daily activities of the PLC quality assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of lookback alerts, quarantine of unsuitable units, and release of source plasma for further manufacture or sales.
Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
Maintains the PLC deviation management system to notify plasma collection centers (internal and external) of nonconformities noted during the plasma receipt and plasma processing.
Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints.
Participates in the writing and revision of policies and procedures related to the PLC.
Monitors the PLC in order to maintain compliance with all applicable regulations.
Hires quality assurance staff and implements training programs, career advancement objectives for quality assurance staff, performs performance appraisals and enacts corrective actions as needed to and including termination.
Meet quality assurance and company financial objectives by monitoring department costs.