What are the responsibilities and job description for the Group Leader Quality Assurance (Pharma/Biotech) position at Pace Analytical Services, LLC?
SUMMARY
Responsible for the day-to-day management of the technical section assigned, typically consisting of approximately four to ten technical staff members. They plan, coordinate, and direct the operations of the technical section assigned to meet client timelines, provide data of appropriate quality, and deliver analytical reports and protocols on time. They are responsible to assure that individuals operate within the quality system and drive individual productivity.
ESSENTIAL FUNCTIONS
- Supervises staff including hiring, training, evaluating performance, providing compensation recommendations, and performance management.
- Ensures that all employees have the necessary training, tools, information, accessories and materials to properly and safely perform their job responsibilities.
- Oversees and supervises broad areas of the operations, such testing, scheduling, inventories, services, communication and general coordination of the lab, services, and field; provide basic technical and quality support to staff members and clients.
- Assign training, laboratory and facility duties. Monitor and review these activities to ensure they are being properly conducted and completed in a timely fashion.
- Clearly documents client requirements within the appropriate format (e.g. Deviations, Project Logs, Project Requirements).
- Acts as the main interface between Pace and the client; ensures that status and progress updates are presented to the client and management as necessary; assists with receiving customer feedback and coordinating resources and responses as required.
- Ensures the accuracy of tests and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
- Assist in equipment and facility maintenance; investigate and facilitate the solving of any equipment / facility problems.
- Participate in writing, reviewing and approving SOPs, calibration procedures, laboratory procedures, validation protocols, maintenance procedures and any other necessary protocols or reports as appropriate.
- Overseeing or reviewing, completing, and processing broad degrees of tests, forms, documents, databases, and related materials and information.
- Provides analysis, interpretation and counsel to staff, management, and functional leaders regarding lab, services, field or testing policies, programs, and practices; involves broad operations and leading implementation and change.
- Analyzes and reviews operations, results, feedback and related lab, services, field or testing information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
- Assists with developing or participating in department 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.
- Assures that the technical area is compliant with Pace's and general regulatory requirements; works closely with the Quality Assurance group to ensure that all quality procedures are being followed and enforced.
- 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.
QUALIFICATIONS
Education and Experience
Required Knowledge and Skills
Required Knowledge
Required Skills
PHYSICAL / MENTAL REQUIREMENTS
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.
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.
