Overview
Quality Engineer Jobs in Arvada, CO at Kratos Industries LLC
Position Title: Quality Supervisor
Reporting Relationship: Quality Manager, Chief Quality and Strategy Officer
Direct Reports: Quality staff as assigned by the Quality Manager
Position Summary: The Quality Supervisor plays a key role in supporting Belmar Pharma Solutions’ commitment to quality and compliance by adhering to local and federal regulations. This position provides oversight of Quality Assurance and Quality Control practices and serves as a mentor and resource for staff. Designed to support internal growth, this role offers an opportunity to gradually develop supervisory experience in a supportive environment. The Quality Supervisor will also assist with special projects assigned by the Quality Manager or Chief Quality and Strategy Officer.
Essential Elements of the Job:
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance to established internal and external standards and guidelines.
Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Participate in all pharmacy inspections, including but not limited to: Board of Pharmacy, NABP, FDA, and DEA
Monitoring Microbiological performance by gathering relevant data and producing statistical reports
Assists in identifying relevant training needs and delivering training
Implement goals, objectives, policies, procedures, and systems pertaining to QA/QC
Attends, helps develop agenda, and actively participates in all quality department meetings.
Collaborate with the Corporate Quality department in writing and implementing Standard Operating Procedures (SOPs)
Assist with nonconformance investigations, deviations, and corrective/preventive actions (CAPA
Document Review including batch records, CAPA, Change Control, Complaints and Deviations
Demonstrate Quality leadership through influence, coordination, and cooperation
Follows all state and federal laws
Assists with validation work as assigned by management
Performs special projects and other job duties as assigned by management
Assist with special projects as assigned by the Quality Manager or Chief Quality and Strategy Officer
Typical Working Conditions:
Must be able to gown for ISO 5/7/8 area
This position may require the handling of laboratory chemicals. Potential exposure to chemicals used in the preparation of compounds (some chemicals are classified as toxic and special safety precautions must be taken when working with these chemicals)
Employees of Belmar Pharma Solutions will work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technology devices as assigned
Note: The statements herein are intended to describe the general nature and level of work being performed by the employee, and are not to be construed as an exhaustive list of responsibilities, duties and skills required of personnel so classified. Furthermore, this does not establish a contract for employment and is subject to change at the discretion of the Employer.
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Title: Quality Engineer
Company: Kratos Industries LLC
Location: Arvada, CO