Good manufacturing practices (gmp) for pharmaceutical excipients
JOB SUMMARY
1. ______________________________________________________________________________
JOB SUMMARY:
Facilitates and monitors team efforts related to process management, supports strategic planning and
deployment initiatives, and helps develop measurement systems to determine organizational improvement.
Determines and evaluates risk(s) and employs knowledge management tools and techniques in resolving
organizational challenges.
Reports to the AVP of Clinical Laboratory Service.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Organization & Leadership
a. Evaluates organizational designs and the effect of changes in the management structure on the organization.
b. In collaboration with operational leadership and other management teams, facilitate initiatives that contribute
to the organizations success.
2. Customer Focus
a. Develop systems to capture patient experience using tools such as complaints data and surveys.
b. In collaboration with operational leadership and other management teams, develop strategies that support
customer service principles.
3. Facilities, Work Environment & Safety
a. Monitors and recommends efficient work environment design that adheres to current governmental
regulations and accrediting standards.
b. In collaboration with operational leadership and other management teams, conduct tracers at regular intervals
to maintain workplace safety.
4. Human Resources
a. In collaboration with operational leadership and other management teams, maintain documented evidence of
personnel training and competency in accordance with CLIA requirements.
b. Recognize team performance in relation to established metrics to meet goals and objectives. Determine how
to reward teams and celebrate their success.
2. 5. Suppliers and Materials Management
a. Facilitate response for vendor notifications that affect accuracy of laboratory testing results and report
applicable events in accordance with regulatory requirements.
b. In collaboration with operational leadership and other management teams, enable timely communication and
review of reports related to vendor notifications.
6. Equipment Management
a. Compiles the calibration, quality control and validation records for submission to the PA State Bureau of
Laboratories and/or upon request of accrediting agencies. Maintains current list of instrumentation used in the
Laboratory for submission during inspections.
b. In collaboration with operational leadership and other management teams, monitors proper method
development, proficiency testing requirements, training and data validation of equipment.
7. Process Management
a. Develops, directs and coordinates the Laboratory Quality Assurance program in accordance with state and
federal regulatory requirements to sustain continuous accreditation status.
b. Conducts both scheduled and unannounced audits of various policies and procedures. Prepares reports of all
findings and maintains documentation of corrective interventions taken.
c. Regularly reviews state and federal regulations for method changes and makes recommendations to modify
standard operating procedures (SOP’s) to comply with approved guidelines.
d. In collaboration with operational leadership and other management teams, identify and recommends training
programs that can improve laboratory operations.
8. Documents and Records
a. Establish documentation policies/procedures and monitor quality performance on a variety of systems by
gathering relevant data from electronic and hard-copy sources.
b. In collaboration with operational leadership and other management teams, maintain document control and
versioning process.
9. Information Management
a. Recommends processes to monitor complete and accurate documentation trail of samples from collection
through analysis utilizing the Lab Information Management System.
b. In collaboration with operational leadership and other management teams, identify relevant subjects and
recommend corrective or preventative actions as applicable.
3. 10. Management of Non-Conforming Events
a. Oversees resolution and reporting of incidents reportable under the law. Ensures proper audit measures are
instituted to define the scope of problems and recommends corrective/preventative measures for issues that are
identified.
b. In collaboration with operational leadership and other management teams, determines possible resolutions to
prevent recurrence.
11. Monitoring and Assessment
a. Coordinates proficiency testing enrollment, ensures timely distribution of samples, reports and monitors
ongoing performance.
b. Conducts internal and external assessments to sustain regulatory compliance.
c. In collaboration with operational leadership and other management teams, evaluates quality indicators that
supports the laboratory’s overall quality management program.
12. Process Improvement
a. Collects, measures, organizes, maintains and analyzes data pertaining to the quality of laboratory testing and
services. Propose programs and activities for process improvement.
b. Works with other teams within GHS to assure coordination of Quality Assurance activities among departments.
Makes periodic reports to Performance Improvement and other committees as applicable.
c. In collaboration with operational leadership and other management teams, minimize errors through process
improvement activities.