Quality Control Manager manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards. Proposes corrective actions to improve compliance with quality specifications. Being a Quality Control Manager recommends new or improved quality control methods, procedures, and/or standards. Requires a bachelor's degree. Additionally, Quality Control Manager typically reports to a head of a unit/department. The Quality Control Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Control Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Quality Control Laboratory Manager
Position Summary:
The Quality Control Laboratory Manager will be responsible for method validation, product release, raw material release, and stability testing for clinical trial material and commercial drug products. They are responsible for leading a team and managing a lab that verifys all products and/or substances meet acceptable quality standards and that they are in accordance with the company’s policies & procedures, FDA policies and procedures, and any applicable cGMP requirements.
The manager will be in charge of all laboratory equipment and MUST have experience with HPLC's and 10 years or more in wet chemistry in the pharmaceutical industry.
Additionally, ensuring compliance, accuracy, and timeliness of specified testing processes, environmental monitoring, data review, data analysis, and data trending of all raw materials, finished formulations, stability samples, client-based & company-based projects, method development, equipment calibrations/qualification and/or transfers, and cleaning study qualifications are all essential responsibilities to supervise and collaborate with QC Analysts and Development Chemists while performing this position.
This is a full-time, non-exempt position that includes a competitive salary and strong benefits. The Quality Control Laboratory Manager will report indirectly to the Site Head / Plant Manager.
Position Description:
Responsibilities
Position Type & Expected Hours of Work
This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Friday. Some responsibilities may require work outside of normal office hours.
Work Environment
Level 2: Office Environment and Laboratory Environment
The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions.
This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee’s daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds.
Travel
No travel is expected for this position.
Required Education & Experience
Preferred Experience & Experience
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice.