Quality Control Manager - Chemistry
Location: Colorado Springs, CO
Working Situation: Onsite
This pharmaceutical company, headquartered in Colorado, excels in the research, development, and manufacturing of both proprietary and generic medications. The company has gained international recognition for its expertise in long-acting injectable drug delivery, with a focus on urology, oncology, and endocrinology. Committed to enhancing patient care, the company develops innovative treatments aimed at improving patients' quality of life. Known for its dedication to excellence, this firm has become a trusted partner in the healthcare industry.
We are seeking a Quality Control Manager to join our reputable pharmaceutical company, known for its innovative advancements in drug development. As a key leader in our team, you will oversee the Quality Control Chemistry (QCC) department at our state-of-the-art manufacturing site. You will lead a talented team, ensuring excellence in all analytical laboratory techniques and investigations. If you have a passion for excellence, proven leadership skills, and expertise in analytical lab techniques and investigations, we want to connect with you!
The Quality Control Manager will be responsible for:
- Organizing, overseeing, and evaluating daily QC Chemistry laboratory operations to maintain Quality Standards and project timelines.
- Communicating priorities related to investigations, change controls, releases, ordering, instrumentation, and CAPAs generated in the QCC laboratories.
- Conducting, authoring, or approving deviations related to QCC Analytical procedures to investigate root cause, determine impact, and corrective and preventive actions.
- Collaborating with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed per company procedures.
- Authoring, revising, and approving controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, and work instructions.
- Leading and participating in third-party and regulatory audits.
- Maintaining a safe working environment in the laboratory, including reporting and trending of SOSPES observations.
The Quality Control Manager will have the following qualifications:
- Bachelor's degree in a scientific discipline, preferably in chemistry or biochemistry
- Ten or more years in a pharmaceutical setting, or a master's degree in a scientific discipline with seven or more years in a pharmaceutical setting.
- Four or more years of experience in a supervisory position required.
If you are interested in the Quality Control Manager opportunity, apply now!
