Pfizer CQ Compliance Specialist in Rocky Mount, North Carolina
A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The CQ Compliance Specialist is responsible for driving compliance projects within CQ aimed at addressing quality issues and compliance gaps, especially those identified during audits. Coordination of these projects and any involved personnel will also be required. Additionally, this individual will manage the timely closure of any CAPAs, remediation activities, and procedural updates related to audit responses and controlled substance deviations.
Demonstrate ability to manage multiple compliance project tasks simultaneously to meet audit commitments and establish project timelines and dates. The incumbent is primarily accountable for the successful and timely coordinating, administrating, and implementing of quality projects. In response to audit observations and comments, manage the timely updating of procedures (SOP, STM, etc.) to ensure the CQ lab maintains a state of compliance.Manage the administration, closure and, where applicable, the execution of CAPAs implemented in response to compliance gaps in the CQ department.Analyze, write, and update procedures and training materials to ensure the compliance of controlled drug substances in the CQ department.Mentor and provide training in Controlled Substances for all analysts and supervisors as needed. Additionally, mentor and provide training for Controlled Drug Agents (CDAs).Manage issuance and closure of logbooks and notebooks for CQ and work as a liaison between CQ personnel and Documentation group.Lead implementation and maintenance of 5S program for CQ.
BS/MS in Chemistry or BS Science DegreeDemonstrated experience in leadership, organizational, and problem solving skills when coordinating and working with all levels of employees.Experience in driving continuous improvement processes for quality/laboratory excellence in an FDA regulated cGMP manufacturing environment. *Thorough and complete understanding of appropriate handling and documentation of controlled substances *Strong organizational skills and ability to multi task across projects and activities.Strong documentation and communication skills as will be required to train all levels of site personnelWilling to learn and develop a career in the pharmaceutical industry.Knowledge of computer applications including MS Office, Excel, LIMS, Access and Trackwise preferred.Must have good English language skills as it relates to written and verbal communications.Follow written and verbal instructions.Work effectively with other laboratory team members.Must be able to exercise leadership and diplomacy when coordinating supervision of non-exempt employees. Communicate results of testing effectively, accurately and in a timely manner.Complete all training, written exams, and laboratory certifications. Flexible to work on any shift temporarily as business needs dictate.Good understanding of 5S program.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
CQ Compliance Specialist Rocky Mount, North Carolina 1054098-1852