This position in based in Clayton, NC.
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.
- 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.
- Meet quality assurance and company financial objectives by monitoring department costs.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in life sciences or related field 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/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.
OCCUPATIONAL DEMANDS
Ability to read and review documents for up to four (4) hours at a time. Ability to stand for extended periods of time - up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds. Ability to travel via automobile and/or airplane.
