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Quality Engineer
Job Description
Location: Frederick, MD (Oniste 5 days a week)
Contract Duration: 12 Months
Pay Range: $30.00 - $35.75 USD hourly on W2
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. Siemens 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
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
Anju Abel's leadership has been instrumental in transforming LanceSoft's global staffing operations. Her focus on innovation, employee satisfaction, and client-centric delivery has led to higher retention rates, a motivated workforce, and enhanced operational efficiency.
"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.