QA Specialist I - Morrisville, NC

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

Responsible for providing advanced oversight of the analysis and administration of various quality policies, programs, and practices in accordance with current Good Manufacturing Practices (cGMP); provides feedback, direction and guidance to employees and management, using advanced professional and technical knowledge of quality or related equipment, testing, and procedures.

• Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information. This includes, but is not limited to manufacturing batch records, 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 or laboratory notebooks.
• Provides fundamental analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; involves standard operations and leading implementation and change.
• Provides standard research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.
• Analyzes and reviews 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 more fundamental 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.
• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

• Bachelor's degree in chemistry, operations, or a closely related field.
• One to two (1-2) years of quality experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.

• Fundamental principles, practices, and techniques of quality.
• Standard understanding of the administration and oversight of quality programs, policies, and procedures.
• Fundamental methods to resolve quality problems, questions, and concerns.
• Standard understanding of applicable quality laws, codes, and regulations.
• Understanding of standard testing tools, equipment, and calibration.
• Computer applications and systems related to the work.
• Principles and practices to serving as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

• Performing fundamental professional-level quality duties in a variety of assigned areas.
• Overseeing and administering standard and varied quality functions.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in a both a team and individual contributor environment.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing fundamental functionals reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion, and prudence in working with those contacted in the course of the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

PHYSICAL/MENTAL REQUIREMENTS:

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

WORKING ENVIRONMENT:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.