Quality Engineer

Integrated Resources, Inc

Frederick, MD

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JOB DETAILS

SALARY

$32–$36 Per Hour

SKILLS

Best Practices, Biotech and Pharmaceutical, Calibration, Communication Skills, Computerized Maintenance Management System (CMMS), Current Good Manufacturing Practice (cGMP), Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), Gene Therapy, IBM Maximo Asset Management, Identify Issues, Manufacturing, Metrics, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Property Management, Quality Control, Quality Engineering, Quality Management, Risk Management, Secondary School, Supply Chain, Team Player, Writing Skills

LOCATION

Frederick, MD

POSTED

2 days ago

Job Title: Quality Engineer
Job Location: Frederick, MD, United States (Onsite)
Job Duration: 12 Months (Possibility of extension)
Pay Rate: $32 - $36/Hr. on W2

Job Description:

Responsibilities:

Provide Quality oversight and guidance for all cGMP Work Orders performed on critical equipment, facility and utilities necessary for commercial and clinical production.
Provide Quality oversight and resolution guidance for all alarms generated by our Equipment Monitoring System (EMS) which actively monitors our critical equipment, facility, and utilities necessary for commercial and clinical production.
Demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices.
Collaborate with project teams and necessary departments (e.g. manufacturing, engineering, product development, quality control, supplier quality, supply chain) in the execution of CQV and CSV, as needed.
Track, review and report metric information as necessary.
Support Quality Engineering functions as necessary, including oversight of validation activities and quality risk management.
Additional duties as assigned.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

Master’s Degree OR
Bachelor’s Degree and 2+ years’ experience in a pharmaceutical or FDA regulated environment OR
AA Degree and 4+ years’ experience in a pharmaceutical or FDA regulated environment OR
High School Degree and 5+ years’ experience in a pharmaceutical or FDA regulated environment.

Preferred Qualifications:

Familiarity with cGMP maintenance planning, execution and closure thru a Computerized Maintenance Management System.
Familiarity with cGMP calibration planning, execution, and closure thru CMMS
Experience in building management systems (e.g. Client Desigo) is a plus.
Experience in CMMS (e.g. BMRAM and/or Maximo) is a plus.
Must be able to prioritize, manage and follow-up on numerous projects and activities
Must exhibit effective written and verbal communication skills
Must be detail oriented and exhibit a high degree of flexibility and initiative
Ability to function efficiently in a diverse, fast paced, changing environment.
Must be able to work independently as well as part of a team.
Ability to think critically, and utilize troubleshooting and problem solving skills
Cell and Gene Therapy experience is a plus.

Quality Engineer

Integrated Resources, Inc

Frederick, MD

About the Company

Integrated Resources, Inc

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