This position is responsible for managing the personnel and requirements of Quality Control at RXQ Compounding. The QC Manager is responsible for the review and verification of compounding activities at RXQ to ensure compliance with cGMP requirements and company policies and procedures. RXQ places a high value on cooperative team dynamics and a positive, “can-do” work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.
· Monitoring Compounding activities and performance of periodic Quality Control verification.
· Daily interaction and partnering with Compounding staff to correct quality issues and for quality improvements.
· Verification and documentation of final testing reports from approved testing facilities.
· Investigation of product non-conformities.
· Investigation of customer feedback (complaints).
· Periodical quality reports for internal and external use.
· Product label control accountability including approval of new label design and verification of label accountability.
· Author and approval of RXQ documentation, specification and processes.
· Determine the need for resource allocation for Quality Control including equipment, personnel and training requirements for Quality Control.
· Manage, train and develop a diverse team of quality control personnel.
· Support company and organizational goals.
· Provide frequent and timely communication to management, internal personnel and suppliers related to compounding processes.
· Determination of the acceptability of RXQ raw material and product based on results of review of documentation, test results and knowledge.
· Be the company microbiology subject matter expert for day to day process decisions and continuous improvement.
· BS preferably in Microbiology, or Chemistry or related science.
· 2 years of relevant experience in aseptic processing.
· 2+ years of managing Quality Unit in cGMP aseptic processing facility.
· Proven experience training teams and developing/coaching direct reports.
· Demonstrated and continued knowledge of ICH, ISO, 21 CFR 210 and 211, USP, FDA Guidance (i.e. FDA Draft Guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act and FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice), good documentation practices and cGXPs.
This position will require near 5 % travel for training, supplier audits and other general business needs.
Competitive Salary and benefits including Medical, Dental, Vision, and Life insurance, as well as, 401K retirement plan.