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Supervisor, Plasma Quality Assurance
- Raleigh, North Carolina, United States
- Raleigh, North Carolina, United States
Über
Location Clayton, NC
Schedule 1st shift - Monday - Friday 5:00am - 1:30pm. Position requires flexibility in working some overtime and weekend shifts (every 3rd weekend). Shift may change with business needs.
The QA Supervisor coordinates and supervises the inspection and release of plasma lots for sale or further manufacture. Verifies critical systems and documentation associated with the destruction of plasma. Ensures compliance to approved procedures. This position has responsibility for the quality acceptance and release of plasma product shipments and supervision of the daily activities of the quality assurance staff.
Responsibilities
Supervises the daily activities of the 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 Plasma Logistic Center (PLC) and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
Reviews and verifies temperature documentation to ensure conformance to appropriate temperature specifications.
Investigates and documents deviations noted because of routine compliance reviews, internal and external audits and customer complaints.
Participates in the writing and revision of policies and procedures related to Source Plasma at the facility.
Monitors Plasma Operations to maintain compliance with all applicable regulations, cGMPs and CFRs. Participates in internal audit for the facility. Interfaces with multiple levels of management and various support and service groups internally and externally.
Trains current and new employees, maintains and updates training records of the QA staff. Supervises the activities of quality assurance staff including hiring, performance management, disciplinary action, and professional development.
Meeting quality assurance and company financial objectives by monitoring department costs.
Education and Experience
Bachelor’s degree in life sciences or a related field is ideal.
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.
Knowledge, Skills and Abilities Strong analytical, organizational and interpersonal skills with extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines. Excellent written, verbal, and leadership skills must be able to make sound decisions that may affect the quality purity or efficacy of a drug product. Anticipates and identifies problems; analyzes situations; considers alternatives; monitors and evaluates results in a systematic manner.
Occupational Demands Ability to read and review documents for up to four hours at a time. Ability to stand for extended periods of time – up to four hours at a time. Ability to lift, tug, pull up to 50 pounds. Ability to travel via automobile and/or airplane.
Equal Employment Opportunity Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
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Sprachkenntnisse
- English
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