QA Specialist II

QA SPECIALIST II (PHARMA BIOTECH) 

 

SUMMARY 

We are actively seeking a candidate to support our Quality Assurance (QA) team. The ideal candidate is one who thrives working in a highly dynamic, fast-paced, team-oriented environment, sharing the common goal of providing our clients with accurate information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical, biologics, and medical device products. 

The QA Specialist is directly responsible for independently auditing analytical projects with minimal guidance for adherence to procedures and regulations related to pharmaceuticals. This includes data package review, some aspects of document control, GLP, walkthroughs of the laboratories, archiving projects, QA oversight of electronic data processing, following cGMPs to ensure compliance to applicable guidelines, administrative tasks, method approvals, protocol approvals, report approvals, internal audits, data auditing, consulting with internal clients to provide guidance and direction, as well as other tasks identified in PLS SOPs. The QA Specialist will collaborate with the Raleigh, NC QA staff on a routine basis to accomplish harmonization. The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of initiative, a desire to collaborate with all departments, and an interest in continuing to acquire new knowledge and skills. 

  

ESSENTIAL FUNCTIONS  

• Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information. This includes, but is not limited to technical records, pertinent laboratory or quality control data, standard operating procedures (SOPs), quality exceptions, logbooks, tracking systems and LIMS data/reports. Data and records may be in the form of electronic or paper records, worksheets, or laboratory notebooks. 

• Provides intermediate to complex analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; involves varied operations and leading implementation and change. 

• Provides various research, feedback, and decisions to resolve management and employee questions and requirements. 

• Analyzes and reviews intermediate to complex operations, results, feedback, and related quality information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management. 

• Ensures the accuracy of various tests, equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies. 

• Assists with developing or participating in quality or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management. 

• Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed. 

• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.