The Quality Control (QC) Compliance Specialist will support the development, implementation, and monitoring of Quality Control activities to ensure compliance to applicable procedures, policies, and regulations. Additionally, the QC Compliance Specialist I will investigate laboratory quality events (Out of Specification, Deviations, CAPAs, etc.), the QC Training program, the QC instrumentation program, and audit readiness.
Duties and Responsibilities:
- Investigate quality events by performing a thorough root cause analysis, plan science-based hypothesis testing, develop an effective Corrective and Preventive Action (CAPA) plan, and prepare a comprehensive report.
- Assist and coordinate with QC to implement and execute CAPAs. This may include creating and revising Standard Operating Procedures (SOPs), coordinating studies or validations, coordinating the purchase of new equipment, and performing effectiveness checks.
- Assist in maintaining the QC instruments within cGMP by scheduling preventive maintenance, calibrations, and re-qualifications with QC and/or third-party vendors.
- Assist with the qualification of purchased equipment. Assist in the development of the installation, operation, and performance qualification documents.
- Work with Quality Assurance (QA) to support and ensure inspection readiness.
- Represent and coordinate activities for QC during audits.
- Identify negative trends in QC performance, such as increased number of quality events (Out of Specification and Deviations).
- Identify gaps in practices, policies, and procedures.
- Develop, maintain, and report statistical analysis and metrics of QC data.
- Inform QC Supervisor and Senior Management of adverse trends.
- Support the development and execution of validation studies and research projects.
- Work with QA Training Specialist to provide necessary technical support for the training program pertaining to the QC department.
- Ensure compliance with all Federal, State, local and company regulations, policies, and procedures related to cGMP, Environment, Health and Safety practices.
- May operate, maintain, and troubleshoot advanced analytical equipment.
- May perform QC testing and other general laboratory duties as assigned.
- Bachelor’s degree in a scientific discipline is preferred and 2 – 3 years of direct applicable experience in the pharmaceutical/biotech industry.
- Experience with Good Manufacturing Practices (cGMP’s) and Good Laboratory Practices (GLP).
- Proficient in Microsoft Office’s Excel, PowerPoint and Word.
Med-Pharmex is an Equal Opportunity Employer. The policy Med-Pharmex is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, protected veteran status, sexual orientation, genetic information, or any other protected category recognized by state and federal laws.